Ablation apparatus and system to limit nerve conduction

ABSTRACT

An electrosurgical probe including a probe body which defines a longitudinal probe axis. The electrosurgical probe also includes a first and second conductive electrode, each disposed along the probe axis. The surface area of the first conductive electrode is greater of the surface area of the second conductive electrode. The ratio of the surface area of the first conductive electrode to the surface area of the second conductive electrode may be adjustable. Another aspect of the present invention is an electrosurgical probe having a probe body which defines a single longitudinal probe axis. The electrosurgical probe of this aspect of the invention further includes more than two electrodes operatively disposed at separate and distinct positions along the axis of the probe body. The electrodes may be selectively connected to one of or a combination of a stimulation energy source, an ablation energy source or a ground for either energy source. Another aspect of the present invention is a method of placing an electrosurgical probe such as described above for specific ablation procedures.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/460,870, filed Jul. 28, 2006 (now abandoned), and also a continuationof U.S. application Ser. No. 11/559,232, filed Nov. 13, 2006 (nowabandoned), both which are a continuation-in-part applications of U.S.application Ser. No. 10/870,202, filed Jun. 17, 2004 (now abandoned),each of which applications are hereby incorporated by reference.

TECHNICAL FIELD

The present invention relates to a method and device used in the fieldof Minimally Invasive Surgery (or MIS) for interrupting the flow ofsignals through nerves. These nerves may be rendered incapable oftransmitting signals either on a temporarily (hours, days or weeks) or apermanent (months or years) basis. One embodiment of the apparatusincludes a single puncture system which features electrodes capable ofcreating areas of nerve destruction, inhibition and ablation.

BACKGROUND OF THE INVENTION

The human nervous system is used to send and receive signals. Thepathway taken by the nerve signals conveys sensory information such aspain, heat, cold and touch and command signals which cause movement(e.g. muscle contractions).

Often extraneous, undesired, or abnormal signals are generated (or aretransmitted) along nervous system pathways. Examples include, but arenot limited to, the pinching of a minor nerve in the back, which causesextreme back pain. Similarly, the compression or other activation ofcertain nerves may cause referred pain. Certain diseases also maycompromise the lining of nerves such that signals are spontaneouslygenerated, which can cause a variety of maladies, from seizures to painor (in extreme conditions) even death. Abnormal signal activations cancause many other problems including (but not limited to) twitching,tics, seizures, distortions, cramps, disabilities (in addition to pain),other undesirable conditions, or other painful, abnormal, undesirable,socially or physically detrimental afflictions.

In other situations, the normal conduction of nerve signals can causeundesirable effects. For example in cosmetic applications the activationof the corrugator supercilli muscle causes frown lines which may resultin permanent distortion of the brow (or forehead); giving the appearanceof premature aging. By interruption of the corrugator supercilliactivation nerves, this phenomenon may be terminated. Direct surgicalinterruption of nerves is however a difficult procedure.

Traditional electrosurgical procedures use either a unipolar or bipolardevice connected to that energy source. A unipolar electrode systemincludes a small surface area electrode, and a return electrode. Thereturn electrode is generally larger in size, and is either resistivelyor capacitively coupled to the body. Since the same amount of currentmust flow through each electrode to complete the circuit; the heatgenerated in the return electrode is dissipated over a larger surfacearea, and whenever possible, the return electrode is located in areas ofhigh blood flow (such as the biceps, buttocks or other muscular orhighly vascularized area) so that heat generated is rapidly carriedaway, thus preventing a heat rise and consequent burns of the tissue.One advantage of a unipolar system is the ability to place the unipolarprobe exactly where it is needed and optimally focus electrosurgicalenergy where desired. One disadvantage of a unipolar system is that thereturn electrode must be properly placed and in contact throughout theprocedure. A resistive return electrode would typically be coated with aconductive paste or jelly. If the contact with the patient is reduced orif the jelly dries out, a high-current density area may result,increasing the probability for burns at the contact point.

Typical bipolar electrode systems are generally based upon a dualsurface device (such as forceps, tweezers, pliers and other graspingtype instruments) where the two separate surfaces can be broughttogether mechanically under force. Each opposing surface is connected toone of the two source connections of the electrosurgical generator.Subsequently, the desired object is held and compressed between the twosurfaces. When the electrosurgical energy is applied, it is concentrated(and focused) so that tissue can be cut, desiccated, burned, killed,stunned, closed, destroyed or sealed between the grasping surfaces.Assuming the instrument has been designed and used properly, theresulting current flow will be constrained within the target tissuebetween the two surfaces. One disadvantage of a conventional bipolarsystem is that the target tissue must be properly located and isolatedbetween these surfaces. Also, to reduce extraneous current flow theelectrodes can not make contact with other tissue, which often requiresvisual guidance (such as direct visualization, use of a scope,ultrasound or other direct visualization methods) so that the targettissue is properly contained within the bipolar electrodes themselves,prior to application of electrical energy.

In recent years, considerable efforts have been made to refine sourcesof RF or electrical energy, as well as devices for applying electricalenergy to specific targeted tissue. Various applications such astachyarrhythmia ablation have been developed, whereby accessory pathwayswithin the heart conduct electrical energy in an abnormal pattern. Thisabnormal signal flow results in excessive and potentially lethal cardiacarrhythmias. RF ablation delivers electrical energy in either a bipolaror unipolar configuration utilizing a long catheter, similar to anelectrophysiology (EP) catheter. An EP catheter consisting of a longsystem of wires and supporting structures normally introduced via anartery or vein which leads into the heart is manipulated using variousguidance techniques, such as measurement of electrical activity,ultrasonic guidance, and/or X-ray visualization, into the target area.Electrical energy is then applied and the target tissue is destroyed.

A wide variety of technology in the development of related systems,devices and EP products has already been disclosed. For example, U.S.Pat. No. 5,397,339, issued Mar. 14, 1995, describes a multipolarelectrode catheter, which can be used to stimulate, ablate, obtainintercardiac signals, and can expand and enlarge itself inside theheart. Other applications include the ability to destroy plaqueformations in the interior of lumens within the body; using RF energyapplied near, or at the tip of, catheters such as described in U.S. Pat.No. 5,454,809 and U.S. Pat. No. 5,749,914. In these applications a moreadvanced catheter which is similar to the EP catheters described abovecontains an array of electrodes that are able to selectively applyenergy in a specific direction. Such devices allow ablation and removalof asymmetric deposits or obstructions within lumens in the body. U.S.Pat. No. 5,098,431 discloses another catheter based system for removingobstructions from within blood vessels. Parins, in U.S. Pat. No.5,078,717 discloses yet another catheter to selectively remove stenoticlesions from the interior walls of blood vessels. Auth in U.S. Pat. No.5,364,393 describes a modification of the above technologies whereby asmall guide wire which goes through an angioplasty device and istypically 110 cm or longer has an electrically energized tip, whichcreates a path to follow and thus guides itself through theobstructions.

In applications of a similar nature, catheters which carry larger energybursts, for example from a defibrillator into chambers of the heart havebeen disclosed. These catheters are used to destroy both tissues andstructures as described in Cunningham (U.S. Pat. No. 4,896,671).

Traditional treatments for the elimination of glabellar furrowing haveincluded surgical forehead lifts, resection of corrugator supercillimuscle, as described by Guyuron, Michelow and Thomas in CorrugatorSupercilli Muscle Resection Through BlepharoplastyIncision., PlasticReconstructive Surgery 95 691-696 (1995). Also, surgical division of thecorrugator supercilli motor nerves is used and was described by Ellisand Bakala in Anatomy of the Motor Innervation of the CorrugatorSupercilli Muscle: Clinical Significance and Development of a NewSurgical Technique for Frowning., J Otolaryngology 27; 222-227 (1998).These techniques described are highly invasive and sometimes temporaryas nerves regenerate over time and repeat or alternative procedures arerequired.

More recently, a less invasive procedure to treat glabellar furrowinginvolves injection of botulinum toxin (Botox) directly into the muscle.This produces a flaccid paralysis and is best described in The NewEngland Journal of Medicine, 324:1186-1194 (1991). While minimallyinvasive, this technique is predictably transient; so, it must bere-done every few months.

Specific efforts to use RF energy via a two needle bipolar system hasbeen described by Hernandez-Zendejas and Guerrero-Santos in:Percutaneous Selective Radio-Frequency Neuroablation in Plastic Surgery,Aesthetic Plastic Surgery, 18:41 pp 41-48 (1994) The authors described abipolar system using two parallel needle type electrodes. Utley andGoode described a similar system in Radio-frequency Ablation of theNerve to the Corrugator Muscle for Elimination of Glabellar Furrowing,Archives of Facial Plastic Surgery, January-March, 99, VI P 46-48, andU.S. Pat. No. 6,139,545. These systems were apparently unable to producepermanent results possibly because of limitations inherent in a twoneedle bipolar configuration. Thus, as is the case with Botox, theparallel needle electrode systems would typically require periodicrepeat procedures.

There are many ways of properly locating an active electrode near thetarget tissue and determining if it is in close proximity to the nerve.Traditional methods in the cardiac ablation field have includedstimulation by using either unipolar and bipolar energy by means of atest pacemaker pulse prior to the implantation of a pacemaker or otherstimulation device. A method of threshold analysis called the ‘strengthduration curve’ has been used for many years. This curve consists of avertical axis (or Y-axis) typically voltage, current, charge or othermeasure of amplitude, and has a horizontal axis (or X-axis) of pulseduration (typically in milliseconds). Such a curve is a rapidlydeclining line, which decreases exponentially as the pulse width isincreased.

Various stimulation devices have been made and patented. One process ofstimulation and ablation using a two-needle system is disclosed in U.S.Pat. No. 6,139,545. The stimulation may also be implemented negatively,where tissue not responsive to stimulation is ablated as is described inU.S. Pat. No. 5,782,826 (issued Jul. 21, 1998).

SUMMARY OF THE INVENTION

One aspect of the present invention is an electrosurgical probeincluding a probe body which defines a longitudinal probe axis. Thus theprobe resembles a single needle and can be placed into tissue through asingle opening. The electrosurgical probe also includes a first andsecond conductive electrode, each disposed along the probe axis. Thesurface area of the first conductive electrode is, in this aspect of theinvention, greater than the surface area of the second conductiveelectrode. The ratio of the surface area of the first conductiveelectrode to the surface area of the second conductive electrode may beequal to or greater than 3:1 or equal to or greater than 8:1. The ratioof the surface area of the first conductive electrode to the surfacearea of the second conductive electrode may be adjustable.

The electrosurgical probe of the subject invention may further include astimulation energy source in electrical communication with either thefirst or the second conductive electrode. Similarly, the electrosurgicalprobe may also include an ablation energy source communicating witheither the first or second conductive electrode. A switch may beprovided for the selective connection of the stimulation energy sourceor the ablation energy source to at least one of the conductiveelectrodes. Either the first or the second conductive electrode may benearer the point of the electrosurgical probe at one end of the probeaxis.

Another aspect of the present invention is an electrosurgical probeincluding a probe body defining a longitudinal probe axis, an activeelectrode operatively associated with the probe body at a first locationalong the probe axis, a stimulation electrode associated with the probebody at a second location along the probe axis and a return electrodeoperatively associated with the probe body at a third location along theprobe axis. The stimulation electrode may be positioned between theactive and return electrodes. The electrosurgical probe of thisembodiment may further include a stimulation energy source in electricalcommunication with the stimulation electrode. The stimulation energysource may provide variable stimulation current. Either the activeelectrode, the return electrode or both may be connected to a ground forthe stimulation energy source. Alternatively, a separate ground may beemployed. This aspect of the present invention may also include anablation energy source connected to the active electrode. The ablationenergy source may be configured to provide variable ablation energy.

Another aspect of the present invention is an electrosurgical probe alsohaving a probe body defining a longitudinal probe axis. At least threeelectrodes will be associated with the probe body at distinct andseparate locations along the probe axis. A stimulation energy sourceconnected to at least one of the electrodes is also included.

The stimulation energy source of this embodiment of the presentinvention may be configured to provide variable stimulation energy. Inaddition, the stimulation energy source may be selectively connected bymeans of a switch to at least one or more of the various electrodes.Similarly, a ground for the stimulation energy source may be selectivelyconnected to one or more of the electrodes.

Another aspect of the present invention is a method for positioning anelectrosurgical probe. The method includes providing an electrosurgicalprobe such as those described immediately above, inserting theelectrical surgical probe to a first position within tissue containing atarget nerve and applying stimulation energy to an electrode. Upon theapplication of stimulation energy, a first response of a muscleassociated with the target nerve may be observed. Thereupon, theelectrosurgical probe may be moved to a second position and a secondapplication of stimulation energy may be undertaken. The method furtherincludes observing a second response of a muscle associated with thetarget nerve and comparing the second response with the first response.The method may also include varying the level of stimulation energybetween the first and second applications of stimulation current. If theelectrosurgical probe provided to implement the method has a thirdelectrode, stimulation energy may be applied to a select third electrodeas well. Certain advantages will be observed with respect to positioningthe electrosurgical probe if stimulation energy is sequentially appliedto first, second, third and subsequent electrodes.

Another aspect of the present invention is a method of managing a systemof minimally invasive surgery. The management method includes providinga practitioner with a minimally invasive surgery system including acontroller. One or more use parameters is stored to memory associatedwith the controller. In addition, an electrosurgical probe having itsown memory is provided to mate with the remaining elements of thesystem. Complementary use parameters are stored in the memory of theprobe. The management method also includes communicating and comparingthe use parameters of the controller with the complementary useparameters of the probe and managing the use of the electrosurgicalprobe according to the use parameters. The use parameters may includeitems such as a practitioner identification designation, a controlleridentification designation and a permitted therapeutic protocol. Otheruse parameters may be devised. This aspect of the present invention mayalso include maintaining a probe use flag in the electrosurgical probememory.

Another aspect of the present invention is a system for minimallyinvasive surgery including a controller associated with memory, anelectrosurgical probe associated with memory, a communication linkbetween the controller and the probe and means for comparing useparameters stored in the memory of the controller with complementary useparameters stored in the electrosurgical probe. In addition, the systemincludes means for managing use of the electrosurgical probe accordingto the use parameters.

Another aspect of the present invention is an electrosurgical probehaving a probe body defining a longitudinal probe axis with multipleconductive electrodes operatively disposed along the probe axis. Theprobe also includes a stimulation current source in electricalcommunication with at least one conductive electrode and a blunt tipoperatively disposed at a first end of the probe.

Another aspect of the present invention is an electrosurgical probeincluding a probe body defining a longitudinal probe axis, multipleconductive electrodes operatively disposed along the probe axis, and astimulation current source in electrical communication with at least oneof the conductive electrodes. This aspect of the present inventionfurther includes a handle operatively associated with the probe body anda switch operatively associated with the handle. The switch is selectedso that selective actuation of the switch may increase or decrease theapplication of stimulation current to at least one conductive electrode.The switch may also be configured such that an alternative actuation ofthe switch allows the application of ablation current to at least oneconductive electrode.

Another aspect of the present invention is a system for minimallyinvasive surgery including an electrosurgical probe, a source ofablation current in electrical communication with the electrosurgicalprobe and apparatus for automatically delivering a therapeutic quantityof energy from the source of ablation current to the electrosurgicalprobe. The therapeutic quantity of energy may include a select waveform,a select energy application duration, or a predetermined power profilethat varies over time. Other attributes of the therapeutic quantity ofenergy are possible.

Another aspect of the present invention is a method of minimallyinvasive surgery which includes automatically supplying a therapeuticquantity of energy from a source of ablation current such as isdescribed above.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 Bi-Polar Driver System.

FIGS. 2, 2A and 2B are schematic diagrams of the bi-polar needle.

FIG. 2A Schematic diagram of the split bi-polar needle.

FIG. 3A Magnified side view of conical bi-polar probe.

FIG. 3B Magnified side view of hollow chisel bi-polar probe.

FIG. 3C Magnified side view of tapered conical bi-polar probe.

FIG. 3D Magnified side view of split conical bi-polar probe.

FIG. 4 Schematic diagram of the bi-polar driver system.

FIG. 5A Ablation Procedure without Auxiliary probe.

FIG. 5B Ablation Procedure with Auxiliary probe.

FIG. 6. Side view Hybrid bi-polar needle for nerve ablation.

FIGS. 6A and 6B illustrate examples of directing energy and limitingablation to smaller regions and thereby avoiding other structures.

FIG. 7 Side view of auxiliary nerve probe.

FIGS. 7A and 7B illustrate side views of auxiliary dual-tipped nerveprobe.

FIG. 8 Side view of guided ablation procedure with auxiliary nerveprobe(s).

FIG. 9 Sample electro-surgery waveforms.

FIG. 10 Side view of visually guided ablation procedure.

FIGS. 11-11A Controller and probe data base structure.

FIG. 12 is a side view of a single axis electrosurgical probe havingequal surface area electrodes.

FIG. 13 is a side view of a single axis electrosurgical probe having twoelectrodes of differing surface areas.

FIG. 14 is a side view of a single axis electrosurgical probe having twoelectrodes of differing surface areas.

FIG. 15 is a side view of a single axis electrosurgical probe havingthree electrodes.

FIG. 16 is a side view of a single axis electrosurgical probe havingthree electrodes and a curved handle portion.

FIG. 17 is a side view of a single axis electrosurgical probe havingmultiple electrodes transverse a nerve.

FIG. 18 is a side view of a single axis electrosurgical probe havingmultiple electrodes parallel to a nerve.

FIG. 19 is a side view of a single axis electrosurgical probe havingmultiple electrodes crossing a nerve at an angle.

FIG. 20 is a flowchart illustrating certain aspects of a systemmanagement method consistent with the present invention.

FIG. 21 is a flowchart illustrating certain aspects of a systemmanagement method consistent with the present invention.

FIG. 22 is a flowchart illustrating certain aspects of a systemmanagement method consistent with the present invention.

FIG. 23A is a flowchart illustrating certain aspects of a systemmanagement method consistent with the present invention.

FIG. 23B is a flowchart illustrating certain aspects of a systemmanagement method consistent with the present invention.

FIG. 23C is a flowchart illustrating certain aspects of a systemmanagement method consistent with the present invention.

FIG. 24 is a flowchart illustrating certain aspects of a systemmanagement method consistent with the present invention.

FIG. 25 is a tabular representation of a therapeutic energy protocolconsistent with the present invention.

FIG. 26 is a graphic representation of a therapeutic energy protocolconsistent with the present invention.

FIG. 27 is a perspective view of an electrosurgical probe featuring amulti-position switch to control stimulation current.

MEDICAL TERMS

Certain terms used herein are defined as follows:

Corrugator supercili muscles—skeletal muscles of the forehead thatproduce brow depression and frowning.

Cepressor anguli oris—skeletal muscle of the corner of the mouth thatproduces depression of the corner of the mouth.

Depressor labii inferioris—skeletal muscle of the lower lip that causesthe lip to evert and depress downward.

Dystonias—medical condition describing an aberrant contraction of askeletal muscle which is involuntary.

Frontalis—skeletal muscle of the forehead that produces brow elevationor raising of the eyebrows.

Hyperhidrosis—condition of excessive sweat production.

Masseter—skeletal muscle of the jaw that produces jaw closure andclenching.

Mentalis—skeletal muscle of the lower lip and chin which stabilizeslower lip position.

Orbicularis oculio—skeletal muscle of the eyelid area responsible foreyelid closure.

Orbicularis ori—skeletal muscle of the mouth area responsible forclosure and competency of the lips and mouth.

Parasymapathetic—refers to one division of the autonomic nervous system.

Platysma myoides—skeletal muscle of the neck that protects deeperstructures of the neck.

Platysma—same as above.

Procerus muscles—skeletal muscle of the central forehead responsible forfrowning and producing horizontal creasing along the nasofrontal area.

Procerus—same as above.

Rhinorrhea—excessive nasal mucous secretions.

Supercilli—a portion of the corrugator muscle that sits above theeyelids.

Temporalis—skeletal muscle of the jaw that stabilized thetemporamandibular joint.

Zygomaticus major—skeletal muscle of the face that produces smiling orcreasing of the midface.

Electrical Terms.

ADC: Analog to digital converter.

ASCII: American standard of computer information interchange.

BAUD: Serial communication data rate in bits per second.

BYTE: Digital data 8-bits in length.

CHARACTER: Symbol from the ASCII set.

CHECKSUM: Numerical sum of the data in a list.

CPU: Central processing unit.

EEPROM: Electronically erasable programmable read only memory.

FLASH MEMORY: Electrically alterable read only memory. (See EEPROM)

UI: Graphical user interface.

HEXADECIMAL: Base 16 representation of integer numbers.

12C BUS: Inter Integrated Circuit bus. Simple two-wire bi-directionalserial bus developed by Philips for an independent communications pathbetween embedded ICs on printed circuit boards and subsystems.

The I2C bus is used on and between system boards for internal systemmanagement and diagnostic functions.

INTERRUPT: Signal the computer to perform another task.

PC: Personal computer.

PWM: Pulse-width modulation.

ROM: Read only memory.

WORD: Digital data 16-bits in length

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates two main components and one optional component, whichare the energy generator 400, the probe 371 (alternate probes aredescribed in FIGS. 3A-D) and optionally probes 771 or 772 that may beused.

In normal operation, the novel probe 371 would combine a unique bipolarconfiguration in a single MIS needle, is inserted into the patient usingMIS techniques. The probe, which may contain and/or convey variousfunctions described later, is initially guided anatomically to theregion of the anticipated or desired location. Various means of locatingthe tip 301 are utilized of placing the zone of ablation in the properarea to interrupt signal flows through the nerve 101.

Device Operation

Many combinations of electrode diameters and tip shapes are possible.The ‘novel’ probe performs a variety of functions, such as stimulation,optical and electronic guidance, medication delivery, sample extraction,and controlled ablation. This bi-polar electrode is designed as a smalldiameter needle inserted from a single point of entry thus minimizingscaring and simplifying precise electrode placement. This low cost,compact design provides a new tool to the art.

Probes may emit fiber optic illumination for deep applications usingelectronic guidance as taught in FIGS. 1 and 8. The invention offers asimple low cost ablation probe that is capable of performing preciseablation while minimizing damage to nearby tissue structures. Themetered ablation energy and precise probe targeting give thepractitioner a tool is also not available in prior art. The practitionerhas unprecedented control of treatment permanence in a minimallyinvasive procedure. Such a procedure is typically performed in less thanone hour with only local anesthetic and would require no stitches orchemicals common to prior medical art.

Stimulation/Ablation

First the probe electrode 301 must be in the desired location relativeto the target nerve 101 (FIG. 4), then the user initiates the treatmentvia switch(s) 410 and 310 using the selected power setting 404 (FIG. 4).The controller configures the generators 411 (FIG. 4) and 412 to theamplitude frequency and modulation envelope, delivering 50 KHz-2.5 MHzof 5 to 500 watts of available energy. The summing junction 413 combinesthe RF outputs as the application requires and passes them to thepulse-width modulator 415 for output power control. The output ofmodulation generator 420 is applied to the multiplier 415 with radiofrequency RF signals 422 and 423. This permits complex energy profilesto be delivered to a time variant non-linear biologic load. All of thesesettings are based on the information provide to the generator by theinstalled probe 371 the selected power 404 settings, and the modulationenvelope 420 (FIG. 4) settings, which are then loaded by the generator421.

For example, both a high amplitude sine wave 910 (FIG. 9), used forcutting, and a pulse-width modulated (or PWM) sine wave 920, used forcoagulation, are well known to electro-surgery art. Precise power ratesand limits of average total power are controlled via integrator 435minimizing damage to nearby structures or burning close to the skin forshallow procedures. Where nearby structures 111 (FIG. 2A) are too closeto be avoided by electrodes such as 371 (FIG. 3A) and 372 (FIG. 3B),additional probe geometries as taught in FIGS. 3D, 6, 6A, and 6B offernovel methods to direct energy and limit ablation to a smaller region,thereby avoiding other structures. For safety a hardwired switch 436disables the power amplifier in the event of a system fault, the probeis unplugged or over power condition, thus protecting both the patientand practitioner.

The output of the modulator 415 is applied to the input of the poweramplifier 416 section. The power amplifier's 416 outputs are then feedinto the impedance matching network 418, which provides dynamiccontrolled output to the biologic loads that are highly variable andnon-linear, and require dynamic control of both power levels andimpedance matching. The tuning of the matching network 418 is performedfor optimal power transfer for the probe, power level, and treatmentfrequencies settled. The system's peak power is 500 watts for thisdisclosed embodiment. Precise control is established by the proximity ofthe tip and the control loops included in the generator itself. Thefinal energy envelope 420 is delivered to probe tip 301 and returnelectrodes 302.

This precise control of energy permits extension of the ablationregion(s), 140 and 1203 (FIG. 10), and the duration of treatmentefficiency. Low or medium energy settings 404 permit temporarynerve-conduction interruption for 3-6 months. Higher energy settings at404 may result in a longer nerve conduction interruption of 1 year topermanent. In the prior art, procedures had little control over durationof termination of such signal flow through the nerve. This inventiongives the practitioner enhanced control of such duration. Patients canevaluate controlled temporary treatment before choosing longer orpermanent treatment options.

A low energy nerve stimulator 771 has been integrated into the system toassist in more precise identification of nearby structures and forhighly accurate target location. Lastly, additional sensors, such astemperature 330, voltage, frequency, current and the like are readdirectly from the device and/or across the communications media 403 tothe probe.

Directed Ablation

In addition to the substantial radially-symmetric ablation patterns withprobes as taught in 371 (FIG. 3A) and 372, switching or dividingablation power to multiple electrodes (FIG. 3D) can generate anasymmetric ablation zone. This high intensity source 608 with probe 610(FIGS. 6 and 6A) minimizes damage to nearby structures 111 or theburning of skin 330 in shallow procedures. Also, FIGS. 2A and 3Didentify probe configurations for selective or asymmetric ablation.

Power Feedback

The power amplifier output 430 and buffered the feedback signals 437 areconnected to an Analog to Digital converter (or ADC) 431 for processoranalysis and control. Said signals 437 control power modulation 420settings and impact the impedance matching control signals 419. Thisintegrated power signal 437 is recorded to the operating-conditiondatabase (FIG. 11) for later procedure review. This power level is alsocompared to reading taken from the probe 1492 (FIG. 11A) as comparedagainst procedure maximums, which if exceeded will in turn disable theamplifier output, thereby protecting the patient from error or equipmentfault. Similarly, limits from the probe and generator sensors such astemperature 330 are also used to terminate or substantially reduce themodulated power levels and ultimately the procedure.

Probe Identification

At power startup, the controller 401 (FIG. 4) reads the probe status andinternal identification kept within the probe itself 331 (and 371) viaserial communications 403 (or bus). Serial communications is usedbecause it is commonly available to most single-chip microprocessors.This or similar methods (e.g. I2C, or SPI) may be used, but thisdisclosed embodiment will use serial for its simplicity. Serialcommunications 403 permits the generator to address and control EEROMmemory 331, temperature sensors 330, processors, ADC and DACs within thesingle-chip microprocessor embedded in the probe itself The user selectsthe desired power setting 404 and based on probe identification readfrom the EEROM or microprocessor 331 makes the appropriateconfigurations. The probe 371 is connected via cable 1334 (FIG. 1) tocontrol unit 400 or generator. This probe is not intended for multipleprocedural uses. So to prevent such use of the probe, the controller 401(FIG. 4) reads the stored time register from ID memory module 331. Ifthe probe's initialized time 1467 (FIG. 11) is zero, the currentreal-time clock 482 value is written to probe's 331's initial timeregister via serial bus 403. If time read on module 331 is non-zero, theprobe's initial time register is added to two (2) times the proceduraltime (based on the probe type) FIG. 14 1420. If that value when comparedto current real-time clock 482, is less than current time, thecontroller will alert the practitioner via display 450, speaker 451 and,flashing probe illumination 608, that the procedure will be terminatedand the probe rendered invalid.

The controller 401 also verifies selected procedure 1415 (FIG. 11) forcompatibility with installed probe. If incompatible, the user is alsoprompted to select a different power setting 404, procedure, or probe371. If probe 371 matches power setting 404, the system enables poweramplifier 416, guide light source 408, and low-voltage nerve simulation732. Both of these procedures are enforced by a mandatory “hand shake”protocol and the serialized information, which must be present andproperly verified by the electronic circuitry for a procedure to beinstituted. During a clinical procedure, information is required to beconveyed by the embedded electronics contained within the probe, whichprovides another way of enforcing this protection and thus againpreventing unauthorized re-use. The ultimate goal is preventcross-contamination between patients. The probe will accomplish this bybeing unique, serialized, and given the above procedures. Once pluggedin, the probe will enter the serial number into the data logging systemvia the serial bus 403 and circuit logic will thereafter prevent re-useof the probe and cross-contamination that would occur. Further, thisscheme will prevent the use of unauthorized third party probes, for theywill not be activated, preventing potential inferior or uncertifiedprobes from being used and presenting potential danger to the patient.

Nerve Target Location Tools

Prior to treatment, the practitioner may use auxiliary probe 771 (FIG.4), to locate target 101 and nearby structures 111 as taught in FIGS. 4,7, 7A, 8, and 10. When needle 771 is in place, the practitioner maylocate and place a mark or marks on the surface of the skin 755 (seeFIGS. 7 and 8) or leaves auxiliary probe 771 in place. For shallowsub-cutaneous procedures, probe tip illumination 448 from source 408 isvisible to practitioner aiding in probe placement to pre-markedlocation.

Location Via Florescence Marker Dye

In other procedures, whereby somewhat larger targets are sought, such asmore diffuse nerve structures or small areas of abnormal growth (e.g.such as cancer) the injection of specially designed dyes that attach totarget structures are used, as taught in FIG. 6A. The probe 610 (FIG. 6)is moved into the proximity of the target 671. The light source 608illuminates quantum-dot/dye tagged antibody 670. The dye fluoresces 675at a frequency/wavelength of a particular material and will typicallyemit light in the visible to infrared (or IR) or potentially otherwavelength regions. The return fiber(s) 680 deliver emissions 675 to thedetector 478 for measurement and are the result is then displayed on bargraph 554 (FIG. 1) and/or an audio tone sounded via speaker 451 based onproximity. Visible and IR light emissions propagate over limiteddistances permitting additional external detectors 678 to be used forshallow targets just under the skin 330. Location via this method issimilar to the electronically guided probe method taught in FIG. 8 whereprobe 610 movement maximizes the signal output when in close proximity.IR emissions propagate and can permit deeper (typically severalcentimeters) detection with optional additional external sensors 678.Unfortunately, many dyes fluoresce in the visible region making externaldetection imposable for deep targets or when obscured by bone. However,probe 610 (FIG. 6A) solves this problem by integrating targetillumination 674, emission 675 detector, ablation, biopsy, andmedication delivery in single compact probe. Electronic probe guidance(FIG. 8) if required is used in combination with florescence detectionto rapidly locate target. The instant invention offers a minimallyinvasive system for locating and treating small/deep tumors and othertissue that are to be ablated, destroyed or removed.

Electronic Probe Guidance

Low energy nerve stimulation current 810 (FIG. 8) assist in locatingdesired treatment region and avoiding nearby structures. Probe 771 isselectable between nerve stimulator and current measurement to/fromauxiliary probe tip 702 (FIG. 8). Return electrode 736 provides a returnpath for local ground 735. Ablation probe switch 367 selects low-energystimulator/receiver and high-energy ablation to/from probe 372.Amplitude of measured guidance current 811 and light 478 are transmittedto display 554, and audio feedback 452 through the speaker 451.

Optical Probe Guidance

Disclosed invention provides optical sources 408 that aid in probeplacement (FIG. 10) by supplementing stimulation source 732 and actingas preliminary guide. Probe 771 is selectable between nerve stimulatoror current 811 measurement and to or from the auxiliary probe tip 702.The ablation probe switch 367 selects low-energy stimulator/receiver orhigh-energy ablation to or from probe 371, 372, 373, and 374. In thismode, the physician operator will have previously placed marks 755 onthe surface of the skin by various means described. The physicianoperator 775 will then see the tip when the 448 if the opticalillumination is turned on. It 448 will provide a bright spot under theskin indicating the location of the tip in relation to the marks 755.The physician 775 will then guide the probe tip 301 into precisealignment under these marks 755 so as to enable ablation of that targettissue 101.

Data and Voice

Real-time engineering parameters are measured such as average power 437,luminous intensity 478, probe current 811, energy 438 and, temperature330 to be recoded into USB memory 438. Simultaneously, the internalparameters disclosed such as frequency 423, modulation 420 and such arerecoded into USB memory 438 as well. Additionally probe, patient, andprocedure parameters (FIG. 11) are written to local storage 438. Thepractitioner dictates text and voice notes via microphone 455, which aresaved to memory 438 (FIG. 1). All data and records are time stampedusing the real-time clock 482. This permits detailed post proceduregraphing and analysis.

Data Transfer

At procedure conclusion, the system transfers the data 438 recorded tothe USB removable memory 1338 and to a file server(s) 1309 and 1307. Inthe disclosed embodiment, data transfer is performed over Ethernetconnection 480. Probe usage records 1460 (FIG. 11) that are stored inlocal memory 438 are then written to removable memory module 1338.Parallel records are mirrored to local storage 1309 and remote server1306 storage 1307 via Ethernet connection 480 or similar means.Sensitive records are encrypted and transferred via secure networkconnection and also written to removable module 1320. The databasecontained on the remote server tracks the following information:equipment by manufacture, probe accessory inventory, usage, billing,repair/warranty exchange information, and program recorders. As a system400 is certified for new procedures 1410 (FIG. 11), the relationaldatabases are automatically updated to reflect new billing/procedurecodes 1416, potential power settings 1417 and the like. This insuresthat the equipment is current and alerts the practitioner to newprobes/procedures as they are developed and certified.

Before further explaining the disclosed embodiment of the presentinvention in detail, it is to be understood that the invention is notlimited in its application or to the details of the particulararrangement shown. The invention is capable of other embodiments.Further, the terminology used herein is for the purpose of describingthe probe and its operation. Each apparatus embodiment described hereinhas numerous equivalents.

FIG. 1 Bi-Polar Driver System

FIG. 1 identifies the two required components of the system, variousmodules and optional items. The two components always utilized during aprocedure will be the energy generator/controller/data storage device400 and probe 371. 400 contains advanced electronic systems capable ofrecognizing a properly authorized probe, preventing re use of apreviously used probe, generating appropriate energy as described,performing safety checks, storing data, and other functions asdescribed. Main functions of 400 may include, but not be limited to,generation of light, generation of location-stimulation currents,generation of ablation energies, data logging, storage, communicationand retrieval, and other functions critical to a MIS procedure. Probe371 and its various forms are single puncture bipolar surgical toolsthat may be used in identifying proper location of its tip 301, inrelation to target tissue 101 which is desired to be ablated, modifiedor destroyed. Probe 771 and its various derivatives may optionally beused to assist in locating and properly positioning tip 301 of probe371.

FIG. 2 Isometric View of the Bi-Polar Probe

Bi-polar probe 310 represents probes 371, 372, 373 shown in FIGS. 3A-Cwith exception to type of needlepoint on the probe. FIG. 3D varies fromthe other because it has a split return probe. Bi-polar probe 310 (notdrawn to scale) consists of insulating dielectric body 309 made from asuitable biology inert material, such as Teflon, PTFE or otherinsulative material, covering electrode 302 except for where 302 isexposed as a return electrode. Conductive return electrode 302 tube isfabricated from medical grade stainless steel, titanium or otherconductive material. Hollow or solid conductive tip electrode 301protrudes from surrounding dielectric insulator 305. Sizes of 309, 302,305, and 301 and its inner lumen (diameter, length, thickness, etc.) maybe adjusted so as to allow for different surface areas resulting inspecific current densities as required for specific therapeuticapplications.

Hollow Electrode 301 often used as a syringe to deliver medication suchas local anesthetic. Tip electrode 301 is connected to power amplifier416 via impedance matching network 418 (FIG. 4). Return electrode(s) 302delivers return current to power amplifier 416 via impedance matchingnetwork 418. Dielectric insulator in the disclosed embodiment is atransparent medical grade polycarbonate acting as a light pipe or fiberoptic cable. Light source LED or laser 408 (FIG. 4) providesillumination at the far end of the probe via fiber opticcable/transparent dielectric 305 for guiding the probe under the skini.e. shallow procedures. In an alternate embodiment dielectric insulatoris replaced with a plurality of optical fibers for viewing andillumination as taught in FIG. 6.

Ablation regions 306 and 140 extend radially about electrode 301generally following electric field lines. For procedures very close toskin 330 a chance of burning exists in region 306. To minimize thechance of burning, a split return electrode probe 374 in FIG. 3D isoffered. Thereby concentrating the current away from region 306 to 140or vice versa. In FIG. 2A, insulator 307 splits the return electrodeinto two sections 302 and 303, dividing return current ratio from 0-50%,which may also be selectively activated. Active electrodes are alsosplit into two sections 301 and 311 so energy may be directed in adesired direction. This electrode configuration is identified on theproximal portion of the probe so the operator may position the needleand electrodes accordingly. FIG. 6 teaches a laser directed ablation formore precise energy delivery.

FIG. 2A Isometric View of Split Bi-Polar Probe.

The bi-polar probe 380 (not drawn to scale) consists of an insulatingdielectric body 309 made from a suitable biologically inert material,such as Teflon PTFE or other electrical insulation, that covers splitreturn electrodes 302 and 303. The disclosed conductive returnelectrodes 302 and 303 are fabricated from medical grade stainlesssteel, titanium or other electrically conductive material. Hollow orsolid split conductive tip electrodes 301 and 311 protrude from thesurrounding dielectric insulator 305. The operation of the hollow/splitconductive tip is very similar to probe tip 310 as taught in FIG. 3D.Ablation regions 1203 (FIG. 10) and 140-144 extend radially aboutelectrode 301 generally following electric field lines. For proceduresvery close to skin 330 a chance of burning exists in region 306. Tominimize chance of burning a split return electrode probe 311 is used,thereby concentrating the current away from region 306 to 140. Forprocedures where there is a risk to nearby structures 111, the ablationregion 1203 must be a non-radial ablation zone. The disclosed splitelectrode 380 permits dividing or splitting energy delivered toelectrode pairs 301/302 and 311/303. The disclosed division or ratiobetween pairs is 0-100%. Dual amplifiers or time multiplexing/switchingmain amplifier, 416 located between electrode pairs, directs energy totarget 101 avoiding 111. This simple switch network reliably ratioselectrical energy while minimizing damage to nearby structures.

FIG. 3A Conical Bi-Polar Needle

Bi-polar probe 371 discloses conical shaped electrode 301 and tip 351for minimally invasive single point entry. Probe diameter 358 is similarto a 20-gage or other small gauge syringe needle, but may be larger orsmaller depending on the application, surface area required and depth ofpenetration necessary. In disclosed embodiment, electrode shaft 302 is30 mm long with approximately 5 mm not insulated. Lengths and surfaceareas of both may be modified to meet various applications such as incosmetic surgery or in elimination of back pain. The conductive returnelectrode 302 is fabricated from medical grade stainless steel, titaniumor other conductive material. The dielectric insulator 305 in thedisclosed embodiment is a transparent medical grade material such aspolycarbonate, which may double as a light pipe or fiber optic cable.The high intensity light source 408 LED/laser (FIG. 4) provides guidanceIllumination 448 at working end of probe. The illumination sourcemodulation/flash rate is proportional to the received stimulationcurrent 810 as taught in FIG. 8. A small diameter electrode permits aminimally invasive procedure that is typically performed with localanesthetic. This configuration may contain lumens for delivery of agentsas described elsewhere.

FIG. 3B Hollow Chisel

The hollow chisel electrode 352 is often used as a syringe to delivermedication such as local anesthetic, medications,/tracer dye. The hollowelectrode may also extract a sample. Dielectric insulator 305 in thedisclosed embodiment is a transparent medical grade polycarbonate andperforms as a light pipe or fiber optic cable. The novel dual-purposedielectric reduces probe diameter and manufacturing costs. Light source408, typically a LED or laser (FIG. 4 not shown), provides Illumination448 at the working end of probe. It provides an illumination source forguiding the probe under the skin. A second embodiment, as taught in FIG.6, dielectric insulator is replaced/combined with plurality of opticalfibers for viewing/illumination.

FIG. 3C Tapered Conical

The bi-polar probe 373 discloses a tapered conical shaped probe forminimally invasive single point entry. It is constructed similarly toprobe 371 as taught in FIG. 3A. Probe tip is not drawn to scale to teachthe tip geometry. In disclosed embodiment, electrode 301 isapproximately 5 mm long and fabricated from medical grade stainlesssteel but may be of various lengths to accommodate specific applicationand surface area requirements. The solid tapered conductive tipelectrode 353 protrudes from tapered dielectric insulator 305.Transparent dielectric insulator 305 also performs as light pipe orfiber optic cable terminated to high intensity light source 408 (FIG. 4)providing illumination 448. The electrode assembly is mounted in anergonomic handle 388 (which has not been drawn to scale). Handle 388holds ablation on/off switch 310, ablation/stimulation mode switch 367,identification module 331 and terminations for cable 1334 (FIG. 13).Temperature sensor 330 (located close to tip) monitors tissuetemperature.

FIG. 3D Split Conical Bi-Polar Probe

Description of this probe is described in both drawings 2A and 3D.Bi-polar probe 374 (not drawn to scale) consists of insulatingdielectric body 309 made from a suitable biologically inert material,such as Teflon, that covers split return electrodes 302 and 303.Conductive return electrodes 302 are fabricated from medical gradestainless steel, titanium or other suitable conductive material. Hollowor solid split conductive tip electrodes 301 and 311 protrude fromsurrounding dielectric insulator 305. Their operation is very similar toprobe tip 380 as taught in FIG. 2A. Solid tapered conductive tipelectrodes 311 and 301 protrude from transparent dielectric insulator305. Dielectric insulator 305 also performs as a light pipe or fiberoptic cable terminated to high intensity light source 408 providingillumination 448.

Probe handle (not drawn to scale) encloses memory module 331, on/offswitch 310 and mode switch 367. Temperature sensor 330 (located close totip) monitors tissue temperature. Split electrode 380 (FIG. 2A) permitsdividing or splitting energy delivered to electrode pairs 301/302 and311/303. Dual amplifiers or time multiplexing/switching main amplifier416 are located between electrode pairs directing energy to target 101avoiding 111 creating asymmetric ablation volume. A small diameterelectrode needle is injected from a single point of entry minimizingscaring and simplifying precise electrode placement.

Connections consist of a tapered dielectric sleeve 309 covering theridged stainless electrode tube 302. Insulating sleeve 309 is made froma suitable biologically inert material, which covers electrode 302.Dielectric 305 insulates conical tipped electrodes 351 and 301.

FIG. 5A Ablation Procedure (Without Auxiliary Probes)

Ablation probe 371 is inserted and directed anatomically into the areawhere the target nerve to be ablated (Box 531) is located. Test current811 is applied (Box 532). If probe is located in the immediate proximityof the target nerve a physiological reaction will be detected/observed(Example: During elimination of glabellar furrowing, muscle stimulationof the forehead will be observed). If reaction is observed, then a markmay optionally be applied on the surface of the skin to locate the areaof the nerve. Power is applied (Box 535) in an attempt to ablate thenerve. If physiological reaction is not observed, (Box 534) the probewill be relocated closer to the target nerve and the stimulation testwill be repeated (Box 536 & 537). If no physiological reaction isobserved, the procedure may be terminated (Box 544). Also, the probe maybe moved in any direction, up, down, near, far, circular, in a pattern,etc. to create a larger area of ablation for a more permanent result.

In Box 537, if stimulation is observed again, then the ablation powermay be set higher (Box 538), alternatively, as mentioned, the needle maybe moved in various directions, or a larger dosage of energy may bereapplied, to form a larger area of ablation for more effective orpermanent termination of signal conduction through the nerve. Afterdelivery of power (Box 540), stimulation energy may be applied again(Box 541). If there is no stimulation, the procedure is completed (Box544). If there is still signal flow through the nerve (stimulation orphysiological reaction) then the probe may be relocated (Box 542) andthe procedure is started over again (Box 533).

FIG. 5B Flow Chart of Visually Guided Ablation Procedure Using AuxiliaryProbes Such as 771 and 772

Auxiliary probes 771 and 772 (FIGS. 7, 7A and 7B) provide a method toquickly and accurately locate target structure 101 and subsequently marktarget location 755. Auxiliary probes may be much smaller (likeacupuncture needles) than ablation probes. Structures are markedtypically with an ink or similar pen allowing the illuminated ablationprobe 371 or other ablation probe to be quickly guided to mark 755.Optionally, non-illuminated probes may be used allowing the practitionerto simply feel for the probe tip. For deep structures, probe 771 (FIG.8) us employed as an electronic beacon. Small current 811, which issimilar to the stimulation current but smaller, from probe tip 702 isused to guide ablation probe 372 (FIG. 8).

Operation 530 (FIG. 5B) inserts auxiliary probe 771 or 772 (FIGS. 7 and7A) thru skin 330 and muscle layer(s) 710 near nerve 101. Target 101depth 766 is measured (FIGS. 7 and 7A) using auxiliary probe markings765. Decision 533 checks if the probe is in position if not adjustmentsare performed in 534. Operation 532 enables nerve simulation current811. When muscle stimulation is obtained or physiological reaction isobtained, Auxiliary probe tip is in place. Depth may be noted by readingmarks 765 and location marks 755 may be made in operation 535. With theprobe in position under mark in operations 536 and 537, operation 538sets power level 404 and closes ablation switch 410. Alternatively,stimulation may be applied directly from the ablation probe as taughtelsewhere. Operation 540 and controller 401 set generator 411 (FIG. 4)frequencies, modulation 420 envelope and enables power amplifier 416 todeliver preset ablation energy. Region 1203 (FIG. 10) shows the generalshape of the ablation region for conical tip 301 for example.

Between each ablation, procedure 540 (FIG. 5C) (nerve conduction) istested in 541. Probe amplifier 416 delivers small nerve stimulationcurrent 811 from electrode 301 or Auxiliary probe 771 or both. Based onthe nerve conduction test 541 if the desired level of conduction isachieved the procedure is compete. Operation 542 moves the probe to thenext position and repeats conduction test 541. If compete, the probe(s)is removed in operation 544. Number and ablation intensity/energy areset by the particular procedure and the desired permanence. Thepractitioner selects the procedure/power level 404 (FIG. 4) andcontroller 401 compares the installed probe via identification 331 (FIG.4) for compatibility with selected procedure. The practitioner isalerted if the installed probe is incompatible with selected power range404.

As an example and not a limitation, five ablation regions (140, 141,142, 143, and 144) are shown in FIG. 10. Ablation starts with area 144,then the probe is moved to 143 and so on to 140. Alternatively, movementmay be during insertion, moved laterally, in a circular manner or othermanner to enlarge the area of targeted nerve destruction. Nerveresponses may be tested after each ablation allowing the practitioner toimmediately check the level of nerve conduction. Probe position andpower adjustments are made before applying additional ablations ifrequired. Accurate probe location tools and methods taught herein permituse of minimal ablation energy thereby minimizing damage to non-targetstructures. This translates to reduced healing time and minimal patientdiscomfort. The instant invention gives the practitioner a new tool toperform a minimally invasive nerve conduction limiting procedure withthe ability to select, temporary or permanent nerve conductioninterruption with a new level of confidence. This new tool offers a lowcost procedure performed typically in office or outpatient setting oftentaking less than one hour with local anesthetic. In contrast to priorart where surgical procedures require stitches and longer healingintervals with limited control of permanence (nerve re-growth).

FIG. 6 Side View of the Bi-Polar Probe 610 With Enhanced Laser Targeting

Probe insertion and placement is same as taught in FIG. 3. Probeconstruction is the same as FIG. 3 with the dielectric 305 havingembedded optical fibers 690 and 680 providing imaging/illumination.Additional fiber(s) 690-691 are illuminated by a high intensity lasersource.

In special cases were target nerve 101 or ablation region 640 is inclose proximity to second nerve 111 or skin 330 bi-polar probes 371 or372 (FIG. 3) create an annular ablation region between electrodes 301and/or 302, potentially damaging nearby structures such as other nerves111. With probe 610 in the desired position, laser 608 (FIG. 4) isturned on target 670 (FIG. 6A) with illuminating fiber(s) 690. Fiber(s)transmitting high intensity laser light to ionized region 640 isilluminated by fiber(s) 690. Simultaneous with laser illumination, RFenergy 470 is delivered to electrodes 301 and 302. A relatively lowimpedance path is created by the high intensity laser illuminationwherein RF energy will follow this newly created path. Thus veryspecific regions may be selected for ablation. By permitting operationat a lower power, energy is concentrated where it is needed andeliminates or reduces damage to nearby structures such as skin 330 ornerves 111. Probe 610 improves on the already very precise ablationtaught in FIG. 3 with the addition of a low power laser (or other typelight source) and fiber delivery system. In the disclosed embodiment adiode pumped Nd:YAG (Neodymium Doped Yttrium Aluminum Garnet) laser isoffered as an example and not a limitation.

FIG. 6A Side View is the Florescence Emission Guided Hybrid Bi-PolarTumor Probe

Probe construction is similar to FIGS. 3A and 6 with dielectric 305embedded with a plurality of optical fibers 380, 690, and 680 forillumination detection/imaging. These enhanced systems and processedaugments the selective nature of previously disclosed probes. Fiber(s)690-691 are illuminated by a high intensity light source(s) 608 which istypically a tunable laser or UV LED. Source(s) 608 (FIG. 4) providesillumination for tagged marker(s) 670 in the disclose embodiment where atunable laser is employed. Excitation/illumination wavelength(s) arespecific to the dye/nano-particle used with marker 670 that is veryspecific for the desired target 671. The marker/tag is typically aprotein specific antigen combined with a florescent marker. The novelprobe illumination permits delivery of intense illumination to thetarget for maximum system sensitivity. Many dyes excited by short(Blue/UV) wavelength light are transmitted poorly in tissue but areeasily delivered by fiber 690. A second application offered for hybridbi-polar ablation probe 610 is for locating/destroying small cancerlesions. The probe addresses cases where surgery is not practical or itdangerous due to location or sub-operable size. Quantum-dot or dyetagged antibody materials 670 are injected into the patients where itattaches to target structure 671. Once tagged, cancer node(s) may belocated, tested, and treated.

FIG. 7 Side View of Auxiliary Single Tipped Nerve Probe

This probe may be used in conjunction with any of the therapeutic probes371 and their derivatives. The needle itself will be very fine innature, such as an acupuncture type needle. By its small size, numerousneedle insertions may be accomplished with no scarring and minimal pain.The probe 771 will be inserted in the vicinity of the target tissuethrough skin 330. The exposed tip of 771, 702 will be exposed andelectrically connected to generator 732 via wire 734. The surface ofprobe 771 is covered with dielectric 704 so the only exposed electricalcontact is surface 702 and return electrode 736. Exposed tip 702 will beadvanced to the vicinity of target 101 and test stimulation current willbe applied. Appropriate physiological reaction will be observed and whenthe tip 702 is properly located, depth will be noted via observing marks765. External mark 755 may be applied for reference. Ablation probe 371may then be advanced to the proximity of the target tissue under the Xmark 755 and ablation/nerve destruction as described elsewhere may beperformed.

FIG. 7A Side View of Auxiliary Dual-Tipped Nerve Probe

Dual tipped probe 772 offers an additional embodiment that eliminatesreturn electrode pad 736. Probe frame/handle 739 holds two fine needles,702 and 701, in the disclosed embodiment that are spaced a shortdistance (a few mm)-mm apart (730). The shaft of conductive needle 701is covered with dielectric insulator 706, similar to the construction ofprobe 771 (FIG. 7). The shaft of the second conductive needle 702 iscovered with dielectric insulator sleeve 703. Electric generator 732provides current to the probes via conductors 734 and 735. Currentoriginates from 701 and returns via electrode 702. Large probe handle739 is drawn out to teach the dual probes. To aide in probe depthmeasurement, markers 765 are printed on needle shafts. Dielectricinsulating sleeves 703 and 706 isolate the needle shaft current frommuscle layer 710. Current applied via generator 732 stimulates the nervedirectly while avoiding muscle 710. Smaller probe tips with smallercurrent permits accurately locating small structures.

Probes 702 and 701 are very small gage needles similar in size to commonacupuncture needles, thus permitting repeated probing with minimaldiscomfort, bleeding, and insertion force. Sharp probes are insertedthru skin 330 and muscle layer(s) 710 near nerve 101. The practitionerlocates target nerve 101, then the skin surface may be marked 755 aslocation aide for ablation step as shown in flow chart (FIG. 5B). Oncethe desired site of ablation is located, ablation probe(s) 610 (FIG. 6),371 and related probes (FIG. 3), may be inserted under skin 330,illuminated 448 by tip 305. They are visible through skin (viaillumination 448 from tip 305) and are guided to mark 755 (FIG. 8). Theobserved intensity 765 from illumination source 305 is used as anestimator of measured depth 765. This simple probe system permits rapid,accurate locating of target structures with minimal pain and injury.Accurate target location permits use of lower ablation energy therebyminimizing damage to nearby structures.

FIG. 8 Side View of Guided Ablation Procedure with Auxiliary NerveProbe(s)

Auxiliary probes 771 and 772 (FIGS. 7 and 7A) are used to accuratelylocate target structure 101. Probe 771 holds a fine conductive needle702 that has a shaft covered with dielectric insulator 704. Electricgenerator 732 provides a small current to the auxiliary probe viaconductor 734 and return conductor 735 via return electrode 736. Thesharp auxiliary probe is inserted thru skin 330 and muscle layer(s) 710near target nerve 101. Dielectric insulating sleeve 704 isolates needleshaft from muscle layer 710. Current is applied via generator 732thereby stimulating the nerve directly while avoiding muscles 710. Priorart probes without insulating sleeve 704 stimulate both the nerve andmuscle simultaneously, masking nerve 101 and subsequently making nervelocation difficult.

Auxiliary probe 771 and 772 provide a method to quickly locate shallowor deep target structures. Shallow structures are typically marked withink pen allowing illuminated ablation probe 371 or its equivalents to bequickly guided to mark 755. Optionally, non-illuminated probes may beused by the practitioner who simply feels for the probe tip. For deepstructures, probe 771 may also be employed as an electronic beacon;small current 811 (which will be lower intensity and different from thestimulating current) from probe tip 702 is used to guide ablation probe372. Amplifier 430 (FIG. 4) detects current from tip electrode 301 forreading and displays it by controller 401. Alternately probe 701 is usedas a receiver detecting current 811 from electrode 301 Moving probe tip301 horizontally 1202 and in depth 766 relative to auxiliary probe 702changes current 810 inversely proportional to distance. Detected signalcurrent 811 isolated and buffered by amplifier 430, is measured and thecurrent is displayed to simple bar graph 554 for rapid reading. Inaddition, audio feedback, in which the tone is modulated by proximity ofprobe tip 351, 352 or equivalent in relation to auxiliary probe tip 702is provided to minimize or eliminate the practitioner having to lookaway from the needle, thus assisting in accurate probe placement.Variable frequency/pitch and volume audio signal are proportional tosensed current 811 that is generated by 452. The tone signal emitted byspeaker 451 (FIGS. 4 and 1) provides a pleasant and accurate method toaide in probe placement. Simultaneously, illumination source 408 ismodulated by amplifier 456 to blink at a rate proportional to the sensedcurrent. This permits the practitioner to quickly and accuracy guideablation probe 372 into position using a combination of audio and visualguides. The audio and visual aides also reduce the practitioner'straining/learning time. The novel real-time probe placement feedbackgives the practitioner confidence that the system is working correctlyso he/she can concentrate on the delicate procedure. Accurate probelocation permits use of minimal energy during ablation, minimizingdamage to non-target structures and reducing healing time and patientdiscomfort.

FIG. 9 A High-Energy Electro-Surgery Sinusoid Cutting Waveform 910

Lower energy pulse width modulated (or PWM) sinusoid 920 for coagulationis also well known to electro-surgery art. Variations of cut followed bycoagulation are also well known.

FIG. 10 Side View of Visually Guided Ablation Procedure

Auxiliary probes 771 and 772 (FIGS. 7 and 7A) have accurately locatedtarget structure 101 and subsequently marked target locations 140 to144. Shallow structures are marked typically with ink pen (755) allowingilluminated ablation probe 371, 372 or equivalent to be quickly guidedto that point. For deep structures, probe 771 is employed as electronicbeacon, small current 811 from probe tip 702 is used to guide ablationprobe 372 as taught in FIG. 8.

Ablation probe 372 is inserted thru skin 330 and muscle layer(s) 710near nerve 101. Illumination source 408 permits practitioner to quicklyand accuracy guide illuminated 448 ablation probe 372 into position.Illumination 448 from ablation probe as seen by practitioner 775 is usedas an additional aide in depth estimation. Selectable nerve simulationcurrent 811 aids nerve 101 location within region 1204. This novel probeplacement system gives practitioner confidence system is workingcorrectly so s/he can concentrate on the delicate procedure. Accurateprobe location permits use of minimal energy during ablation, minimizingdamage to non-target structures and reducing healing time and patientdiscomfort.

Region 1203 shows the general shape of the ablation region for conicaltip 301. Tip 301 is positioned in close proximity to target nerve 101.Ablation generally requires one or a series of localized ablations.Number and ablation intensity/energy are set by the particular procedureand the desired permanence.

Five ablation regions are illustrated 140, 141, 142, 143, and 144;however, there could be more or less regions. Ablation starts with area144, then the probe is moved to 143 and so on to 140, conversely,ablations could start at 140 and progress to 144. Also, the practitionercould perform rotating motions, thus further increasing the areas ofablation and permanence of the procedure. Between each ablationprocedure 540 (FIG. 5C), a small nerve stimulation test current 811 isemitted from electrode 301. The approximate effective range of the nervestimulation current 811 is shown by 1204. Testing nerve response aftereach ablation allows the practitioner to immediately check level ofnerve conduction. Without probe 372 removal, the practitioner receivesimmediate feedback as to the quality of the ablation. Then minor probeposition adjustments are made before conducting additional ablations (ifrequired).

FIGS. 11-11A Controller and Probe Data Base Structure

Controller 101 maintains local probe 1460, patient 1430, and procedure1410 databases. All work together to insure correct probes and settingsare used for the desired procedure. Automatically verifying that theattached probe matches selected procedure and verifying probeauthentication and usage to avoid patient cross contamination or use ofunauthorized probes. Automatic probe inventory control quickly andaccurately transfers procedure results to the billing system.

FIG. 11—Procedure Parameters Code(s) Database 1410

From a touch screen, the practitioner selects the desired procedure fromlist 1410. For example “TEMPORARY NERVE CONDUCTION” 1411, “SMALL TUMOR1CC” 1412, and “SMALL NERVE ABLATE” 1413 are a few of the choices. Eachprocedure has a unique procedure code 1416 to be used in the billingsystem. Power range parameter 1417 is a recommended power setting viapower level control 404. The recommended probe(s) Associated withprocedure 1415 and power range parameter 1417 are listed in parameters1419. With the probe connected, the part number is read from memory 331(FIGS. 1, 3 and 4) and compared to list 1419. The total power parameter1418 is the maximum energy that the system may deliver for thisprocedure and is determined by the procedure code, probe being used andsoftware parameters. These parameters may be modified, updated andchanged as required by addition of new probes and proceduresallowed/approved. Power is delivered, measured and totaled withintegrator 435 (FIG. 4). The power integration circuit is designed as ahardwired redundant safety circuit that turns off the power amplifier ifmaximum energy is exceeded. This novel feature protects patients fromsystem fault or practitioner error. Standard procedure time 1420 isdoubled and added to current RTC 482 then written to probe memory 331(in FIG. 1).

FIGS. 11 & 11A—Probe Usage Authorization Database 1460

From touch screen 450 (FIGS. 1 and 4) practitioner selects desiredprocedure from list 1410. Probe 371 and equivalents (FIGS. 3A-D) type isselected from recommended list 1419 and is connected via cable 1334(FIG. 1) to control unit 101. Once connected, controller 401 (FIG. 4)reads the stored time register from ID memory module 331 (FIG. 1). Ifstart time 1487 read is zero (factory default), current real time clock482 (FIG. 4) is written to database 1460 in the start time field 1467,1430 and 1435. Simultaneously, twice the standard procedure time 1420parameter is added to RTC 482 and written to time register 1487 viaserial bus 403. If probe start time 1487 reads (331) non-zero, the valuecompared to real time clock 482. If greater than current time plus twicethe standard selected procedure duration 1420, the controller alerts thepractitioner via display 450, speaker 451 and flashing probeillumination 608 of previously probe used condition. To correct thesituation, the practitioner simply connects a new sterile probe andrepeats the above process. FIG. 13 teaches additional detail regardingprobe verification usage and related database operations. Periodicallycontroller 401 performs the above verification to alert practitionerthat he/she has forgotten to change probe(s).

During the procedure (FIG. 10), various parameters such as peaktemperature 1473, power 1472, impedance, etc. . . . are read, scaled,stored and displayed. Parameters such as procedure start 1467; end time1468, serial number 1469, and part number 1468 are recorded as well.Critical parameters are written to local high-speed memory 438 fordisplay and analysis. On a time permitting or end of procedure, data ismirrored to removable USB 1320 memory stick 1338. Probe specificparameters 1463 are copied and written to probe memory 1338 for use atprobe refurbishment facility. Database checksum/CRC(s) 1449, 1479, and1499 are check and updated as required. Faults such as shorts(dielectric 305 (FIG. 3) breakdown) that are detected are saved to errorfield 1494 and 1474. If network connection 1305 is available, emailrequest for replacement probe are automatically sent to repair/customerservice center 1308. Defective probe 374 with saved failure information1494 is returned for credit and repair.

Use of a USB memory stick permits continued operation in the event of anetwork 1326 failure Data is loaded to memory 1338 for simple transferto office computer 1306 (FIG. 1) for backup. Commonly available USBmemory sticks 1320 have large data capacities in the tens to hundreds ofmegabytes at a low cost with long retention times. USB memory sticksalso can support data encryption for secure transfer of patient data.Sealed versions are available as well compatible with chemicalsterilization procedures.

If computer network 1326 such as Ethernet 802.11 or wireless 802.11x isavailable, files are mirrored to local storage 1309, remote server 1307.The remote server (typically maintained by equipment manufacture) can beremotely update procedure(s). To insure data integrity and systemreliability a high availability database engine made by Birdstep ofAmericas Birdstep technology, Inc 2101 Fourth Ave. Suite 2000, SeattleWash. is offered as an example. The Birdstep database supportsdistributed backups, extensive fault and error recovery while requiringminimal system resources.

FIG. 11—Patient/Procedure Database 1430

From a touch screen, the practitioner selects or enters patient namefrom previous procedure 1430 and creates a new record 1433. Similarly, aprocedure is selected from 1410 (for example “TEMPORARY NERVECONDUCTION” 1411, “SMALL TUMOR 1CC” 1412, and “SMALL NERVE ABLATE”1413). Each procedure has a unique procedure code 1416 that is used forthe billing system. Other information such as practitioners name 1440,date 1435 is entered to record 1433. As taught above probe appropriatefor the procedure is connected and verified, part 1470 and serial number1469 recorded.

FIG. 11—Voice and Notes

The practitioner enters additional text notes to file 1442 or recordsthem with microphone 455 (FIG. 5) to wave file 1445 for later playbackor transcription. The instant invention permits temporary/permanentnerve conduction interruption. Thus, procedures are performed atintervals from months to years apart. A hands free integrated voicerecorder is extremely useful. Detailed text and voice notes made whileprobing/ablating are also recording specific settings, and patientresponse. A feature that is very helpful when reviewing treatmentprogress and saves valuable time instead of writing notes. Practitionersplay back voice/wave files 1445 with standard audio tools a his/or hersdesk. Audio files 1445 can be sent via email or file transfer fortranscription, updating note field 1442.

At the end of procedure, records are updated and stored to memory 438.Backup copies are written to USB 1320 memory stick 1338 (FIG. 1). Ifcomputer network 1326 such as Ethernet 802.11 or wireless 802.11x isavailable, files are mirrored to local storage 1309, remote server 1307.Patient name 1436, procedure date 1435, and procedure codes 1416 areautomatically transferred via network or USB device 1320 to billingsystem 1306. USB memory stick permits continued operation in the eventof a network 1326 failure. Data is loaded to USB memory 1338 for simpletransfer to office computer 1306 (FIG. 1) for backup. USB memory sticks1320 have large data capacities in the tens to hundreds of megabytes ata low cost with long retention times. USB memory stick also support dataencryption for secure transfer of patient data. Insuring patient isaccurately billed with minimal office paper work. Probe inventory isautomatic maintained with replacement probes automatic shipped asneeded.

Alternative Probe Configurations

FIG. 12 is a schematic view of an alternative embodiment of a singleaxis electrosurgical probe 2000 having a longitudinal probe axis 2001,which is similar to the probe of FIG. 3. However, probe 2000 of FIG. 12features substantially equal surface area conductive electrodes 2002 and2004 located along a longitudinal axis. A probe 371 also havingsubstantially equal surface area electrodes 301 and 302 is shown in FIG.3A.

In an equal electrode surface area implementation, one of the conductiveelectrodes 2002, 2004 may be selectively connected to a stimulationcurrent source or an ablation current source as described above. Theother electrode 2002, 2004 may be unconnected or connected as a groundor return path for the connected current source. In the embodiment shownin FIG. 12 conductive electrode 2002 is configured to be connected tothe ablation source making electrode 2002 the active electrode. Thuselectrode 2004 is in this embodiment a return electrode. Eitherelectrode 2002, 2004 may be connected to a current source or return withappropriate switches.

Since electrodes 2002 and 2004 have substantially equal surface area,the local heating formed upon the application of RF ablation energy tothe active electrode 2002 results in a heating zone having asubstantially symmetrical ellipsoid form.

The single axis electrosurgical probe 2000 of FIG. 12 also features adielectric insulator 2006 positioned along the probe axis between theconductive electrodes 2002 and 2004. The dielectric insulator 2006 mayhave any suitable length, and probes with alternative length insulatorsmay be manufactured for specific ablation procedures. Varying the lengthof the dielectric insulator 2006 varies the gap dimension 2008 betweenthe electrodes 2002 and 2004. Varying the gap dimension 2008 providesfor optimization of the current density within the ablation zone, variesthe length of the ablation zone and permits the use of higher voltages,if desired. Thus, the gap dimension may be selected in conjunction withother parameters such as electrode surface area and ablation current toachieve select ablation volumes and tissue temperatures for specificapplications.

The probe 2000 of FIG. 12 also features a blunt tip 2010 rather than theconical tip 351, chiseled tip 352 or other tips of FIG. 3. The blunt tip2010 of FIG. 12 has a smooth rounded profile and is advantageous incertain instances to allow the probe to be easily advanced andmaneuvered under the skin minimizing the risk of puncture or the cuttingof adjacent tissue or anatomical structures. Thus, a blunt tip 2010 maysignificantly reduce the bruising or other trauma associated with aprocedure.

The probe 2000 of FIG. 12 may include a sensor 2012. The sensor may be atemperature sensor 2012. A temperature sensor provides for activetemperature monitoring within the ablation zone. Alternatively, a singleaxis electrosurgical probe of any configuration may be implemented witha Kalman filter as taught by Conolly U.S. Pat. No. 6,384,384 whichpatent is incorporated herein by reference in its entirety. Kalmanfilters are also used to estimate tissue temperature within an ablationvolume. Kalman filters are suitable for use where well-defined tissuestate changes occur at specific temperatures due to protein denaturationsuch as the denaturation of collagen at 65C. Kalman filter temperaturemonitoring is advantageous because the bulk and cost of a separatetemperature sensor can be avoided.

FIG. 13 is a schematic view of an asymmetrical single axis probe 2014also defining a longitudinal probe axis 2015. The probe 2014 features afirst conductive electrode 2016 and a second conductive electrode 2018having different surface areas. In the embodiment shown in FIG. 13, thefirst electrode 2016 is an active electrode and the second electrode2018 having a larger surface area is a return electrode. A probe havingany surface area ratio between an active and return electrode may befabricated and used to achieve specific ablation results. In addition,the relative positions of the active electrode 2016 and the returnelectrode 2018 with respect to the tip of a given probe may be switched.In one embodiment the ratio of the active electrode 2016 to the surfacearea of the return electrode 2018 is 1:3. Other ratios including 1:8 maybe implemented to achieve specific results. The surface area ratio mayfurther be adjustable using a sleeve or other mechanism which willshield or cover a portion of on or both electrodes thus increasing ordecreasing the length of the gap defining dielectric insulator 2019.Generally, asymmetrical electrode surface areas will result inasymmetrical heating and ablation because of the higher current densityof the RF ablation energy at the electrode with smaller surface area.For example, upon the application of RF energy to the active electrodeof the FIG. 13 embodiment, a tissue volume proximal the active electrode2016 may be asymmetrically heated due to the greater current densityresulting from the relatively small surface area of the active electrode2016. Asymmetrical tissue heating coupled with precise RF powerintegration taught herein and various probe geometries permits theformation of selected repeatable and controlled ablation volumes.

FIG. 14 schematically illustrates an alternative asymmetrical probe2020, which is similar in many respects to the asymmetrical probe 2014of FIG. 13. The asymmetrical probe 2020 of FIG. 14, however, features anactive electrode 2022 having a surface area greater than that of thereturn electrode 2024. In the FIG. 14 embodiment current density ishigher at the relatively smaller surface area electrode 2024, thusablation energy is concentrated in the dielectric insulator gap 2025between the electrodes 2022 and 2024 nearer return electrode 2024 andaway from the tip of the probe.

FIG. 15 is a schematic view of one embodiment of a multiple electrodeprobe 2026. The multiple electrode probe 2026 includes a substantiallyneedle-shaped probe body 2028 which defines a longitudinal probe axis2029. More than two electrodes are associated with the probe body andpositioned at various locations along the probe axis. In the FIG. 15embodiment the electrodes include an active electrode 2030, a returnelectrode 2032, and a stimulation electrode 2034. In this embodiment theactive electrode is positioned near the tip of the multiple electrodeprobe 2026, the return electrode 2032 is positioned away from the tipand the stimulation electrode 2034 is positioned between the activeelectrode 2030 and the return electrode 2032. It should be noted thatthe position of the various electrodes with respect to each other andthe tip may be varied to achieve specific ablation and probe positioningadvantages. In addition, the connection of any given physical electrodeas an active electrode, return or stimulation electrode may be varied atthe discretion of the user with a simple switching mechanism between theelectrode and the ablation or stimulation energy sources. Alternatively,a separate ground or return path 2035 may be utilized with anyconfiguration of electrodes. The various electrodes of the multipleelectrode probe 2026 are separated by a first dielectric insulator 2036and a second dielectric insulator 2038. FIG. 16 schematicallyillustrates the multi-polar probe 2026 of FIG. 15 with the addition of acurved section 2040 opposite the portion of the probe body 2028associated with the electrodes. The curved section 2040 may in certaininstances allow the practitioner to achieve optimal probe positioningwith a minimum of unnecessary tissue disruption. A multiple electrodeprobe 2026 may be implemented with dielectric insulators 2036, 2038 ofvarying dimensions, sensors or electrodes of different surface areas,all as described above, to achieve desired ablation results.

FIG. 17-19 schematically illustrates an alternative embodiment of amultiple electrode probe 2042. The multiple electrode probe 2042 of FIG.17-19 includes a probe body 2044 which defines a longitudinal probe axis2045. Multiple electrodes 2046-2062 are associated with the probe body2044 at separate locations along the probe axis. In the embodiment shownin FIG. 17-19 the electrodes are uniformly sized and spaced. It isimportant to note, however, that different sizes of electrodes andnon-uniform spacing of the electrodes may be implemented to achievespecific ablation results. Preferably, each of the electrodes 2046-2062may be selectively connected with one or more switches to a stimulationcurrent source, an ablation current source, a ground for the stimulationcurrent source a ground for an ablation energy source or leftunconnected. As described in detail below, the flexibility provided byswitched connection of each electrode to a current source or groundprovides certain advantages in probe location and ablation. In addition,the multiple electrode probe 2042 could be deployed in conjunction witha separate return electrode 2064, typically placed in contact withtissue away from the ablation site.

Placement Methods

Several methods of properly positioning a probe adjacent to a selectednerve for ablation energy application are discussed above. For example,probe placement methods featuring florescence marker dyes, optical probeguidance and electronic probe guidance with the use of low energy nervestimulation current are discussed in detail. Certain of the alternativeprobe configurations as illustrated in FIGS. 13-19 provide for refinedprobe placement methods using variations of the basic electricalstimulation techniques described above.

The single axis electrosurgical probe 2000 of FIG. 12 or the asymmetricprobes 2014, 2020 of FIGS. 13 and 14 may each be properly positionedusing an iterative technique, as described above with reference to FIGS.5A-C. The iterative placement method may be refined for uses withmultiple electrode probes such as are depicted in FIGS. 15-19.

For example, the FIG. 15 embodiment of a multiple electrode probe 2026includes a separate stimulation electrode 2034. The stimulationelectrode 2034 is located along the longitudinal axis 2029 of the probebody, typically though not necessarily between an active electrode 2030and a return electrode 2032. During the stimulation and positioningphases of a probe placement procedure the active electrode 2030, returnelectrode 2032 or a separate electrode 2035 not associated with theprobe body 2028 may serve as the ground for the stimulation currentsource. As is described above with respect to FIG. 5 a practitioner willtypically monitor target nerve response by observing muscle reactionelicited by the stimulation current as the multiple electrode probe 2026is iteratively guided closer to the target nerve 101. The level ofstimulation currently applied may be adjusted to increase or decreasethe effective stimulation range depending upon the muscle responseobserved by the practitioner. Typically, stimulation current will becontinuously or stepwise reduced with a switch or other control todecrease the stimulation range as the stimulation electrode 2034 isguided in close proximity to the subject nerve 101, assuring that thenerve is ultimately placed adjacent to the stimulation electrode.

In probe embodiments where the stimulation electrode is positioned inbetween the ablation electrodes 2030, 2032, the above describediterative method guarantees that the target nerve is positioned withinan elliptical ablation zone 2064 (see FIG. 16) which will be formedbetween the active electrode 2030 and return electrode 2032 upon theapplication of RF ablation energy.

FIG. 17-19 shows an alternative embodiment of a multiple electrode probe2042 placed in various orientations with respect to a target nerve 2066.For example in FIG. 17, the multiple electrode probe 2042 is placedtransverse the nerve 2066, in FIG. 18 the multiple electrode probe 2042is placed parallel to a portion of the nerve 2066 and FIG. 19 shows themultiple electrode probe 2042 placed across the target nerve 2066 at anangle. As is described in detail above, each of the electrodes 2046-2065may preferably be selectively connected to a stimulation current source,an ablation energy source, a ground or left unconnected. The electrodes2046-2062 may be connected manually or switched and activatedelectronically.

The multiple electrodes of the FIG. 17-19 embodiment of the multipleelectrode probe 2042 provides for certain advanced placement andablation procedures. For example, FIG. 17 illustrates a method forlocating and selectively ablating a target nerve 2066, which runssubstantially transverse the probe at a point along the axial length ofthe probe 2042. This placement method features the practitionerinitially positioning the probe across the target nerve 2066. Theelectrodes 2046 through 2062 are then activated sequentially withstimulating current, in adjacent active/ground pairs (bipolar mode) orindividually with reliance upon an external ground 2064 (mono-polarmode). The practitioner may then observe the response of one or moremuscles associated with the target nerve as stimulation current isapplied to successive electrodes 2046-2062.

For example, with reference to FIG. 17, stimulation current may beapplied between electrodes 2046 and 2048. The practitioner notes thatthere is no corresponding muscle response. Stimulation current may nextbe applied between electrodes 2048 and 2050. Again, no muscle responseis observed by the practitioner. Sequentially, stimulation current isthen applied to successive electrode pairs. When the stimulation currentis applied between electrodes 2054 and 2056 there may be a mild muscleresponse. When the stimulation current is applied between electrodes2056 and 2058 however, a strong muscle response will be observed.Continuing on, the stimulation is then applied between electrodes 2058and 2060. Here a greatly reduced muscle response is observed indicatingthat the nerve is crossing the probe substantially between electrodes2056 and 2058. Subsequently, ablation energy may be applied betweendesignated electrodes 2056 and 2058 to ablate nerve 2066.

FIG. 18 illustrates a similar nerve location and ablation procedurewherein the nerve 2066 is substantially parallel to and adjacent to theaxial length of the probe 2042 adjacent electrodes 2048 through 2056. Inthis second example the practitioner first applies stimulation currentis applied between electrodes 2046 and 2048. A mild muscle response orno muscle response may be observed. When stimulation current is appliedbetween electrodes 2048 and 2050, a strong muscle response is noted bythe practitioner.

Sequentially, the stimulation current is then applied between electrodes2050 and 2052 with similar strong muscle response observed. Thissequential stimulation and response process is observed through theactivation of electrodes 2056 and 2058 where the muscle response issubstantially diminished or not observable. This is an indication thatelectrodes 2048 through 2056 are all in contact with the nerve 2042. Theelectrodes 2048 through 2056 may then be switched to the ablationcurrent source activated and sequentially or simultaneously in bi-polarpairs or individually in bi-polar or mono-polar mode to ablate the nerve2042. The nerve could be ablated along a select length defined by thenumber of electrodes activated by the practitioner. This method couldalso be implemented in mono-polar mode whereby stimulation or ablationenergy is applied between one or more electrodes 2046 through 2062 and aseparate return electrode applied externally on the body.

FIG. 19 illustrates a substantially similar nerve location and ablationprocedure wherein the multiple electrode probe 2042 crosses the nerve2066 diagonally or at an oblique angle to the probe axis. Thus, FIG. 19illustrates a method for angular positioning of the probe 2042 relativeto the nerve 2066. In this example stimulation current applied asdescribed above at electrodes 2052, 2054, and perhaps 2056 would resultin a response in the associated muscle. If a larger number of electrodeselicit a muscle response, this is an indication of a broader nerve/probecontact area resulting from a more parallel contact placement of theprobe 2042 relative to the nerve 2066. Such a determination of angularplacement can be enhanced by fabricating a probe with relatively shortdistance between adjacent electrodes, relative to the diameter of anerve of interest. The practitioner may also maneuver the probe toattain a muscle response from more or less electrodes as desiredproviding the opportunity to ablate a greater or lesser length of thenever without axially repositioning the probe.

The above methods of angular probe positioning and sequentialstimulation may be combined with the iterative techniques also describedabove. For example, the stimulation current generator may be set at arelatively high level initially and reduced when the general location ofthe nerve with respect to certain electrodes is determined.

For example, the stimulation current threshold (to elicit an observableresponse) between electrodes 2048 and 2050 of FIG. 19 would be higherthan the threshold between electrodes 2050 and 2053. This informationcould be indicated graphically, numerically or audibly to allow thepractitioner to reposition the probe for more parallel or moretransverse positioning of probe 2042 relative to nerve 2066.

The apparatus and methods described above may be implemented withvarious features which enhance the safety, ease of use and effectivenessof the system. For example, the probe may be implemented with anergonomic and functional handle which enhances both operationaleffectiveness and provides for the implementation of safety features.Individual probes may be carefully managed, preferably with systemsoftware to assure that a selected probe functions properly, is sterileand not reused, and that the proper probe is used for each specifictreatment procedure. Similarly, safeguards may be included with thesystem to assure that the operator is certified and trained for thespecific treatment protocol selected. Various treatment managementmethods and specific treatment therapies may be selected for both thebest results and for enhanced patient safety. In one embodiment, thetreatment, therapeutic, and safety methods may be implemented with andrigorously controlled by software running on a processor associated withthe ablation apparatus and system as is described in detail below.

System Management Method

The concurrent goals of patient safety, procedure efficiency andtherapeutic success can be advanced through an effective systemmanagement method. A system management method such as is describedherein may be implemented through computer software and hardwareincluding computer processors and memory operating within or inassociation with the control console and the probe system describedherein. Various interfaces between a practitioner, the control console,and the probe system may be present. In addition the hardware associatedwith an ablation system, including the probe stimulation current source,ablation current source, and the probe system may be in communicationwith and provide feedback to the system processor. Alternatively, thesteps of the system management method could be implemented manually.

In a software and processor based system embodiment, the techniquesdescribed below for managing an electrosurgical probe and system may beimplemented as a method, apparatus or article of manufacture usingstandard programming and/or engineering techniques to produce software,firmware, hardware, or any combination thereof. The term “article ofmanufacture” as used herein refers to code or logic implemented with orstored upon a medium or device (e.g., magnetic storage medium such ashard disk drives, floppy disks, tape), optical storage (e.g., CD-ROMs,optical disks, etc.), volatile and non-volatile memory devices (e.g.,EEPROMs, ROMs, PROMs, RAMs, DRAMs, SRAMs, firmware, programmable logic,etc.). Code in the computer readable medium is accessed and executed bya processor. The code in which implementations are made may further beaccessible through a transmission media or from a file server over anetwork. In such cases, the article of manufacture in which the code isimplemented may comprise a transmission media such as networktransmission line, wireless transmission media, signals propagatingthrough space, radio waves, infrared, optical signals, etc. Of course,those skilled in the art will recognize that many modifications may bemade to this configuration without departing from the scope of theimplementations and that the article of manufacture may comprise anyinformation bearing medium known in the art.

FIGS. 20-24 include a series of flow charts detailing various aspects ofa method of probe management, system certification, system licensing andoperator training consistent with the present invention. Although themethod steps included herein are shown in a particular order on FIGS.20-24, other orders of operations are within the scope of the disclosedmethod. Certain aspects of the method, for example the practitionerauthorization method illustrated in FIG. 20, are executed beforedelivery of the system to a practitioner to assure that the system isset up appropriately according to the practitioner's license and skillscertification. Other aspects of the method such as probe ordering andprobe self test (FIG. 21 and FIG. 22) are performed at the probedistribution point to assure that electrosurgical probes to be shippedare registered, tested, and identified in accordance with thepractitioner's system, license, and treatment certification. In FIGS.23A-C, the patient side elements of the overall probe management methodare described as these steps will be followed interactively by thepractitioner at or before the time of treatment. Any suitable computerinterface may be provided to accept input into the system from thepractitioner. As described above in paragraphs 0194-0204 a touch screenmonitor, voice input, proximity sensor, or other interface for rapidlyproviding input is advantageous for avoiding input delays and to enhanceinput accuracy.

One aspect of a system management method consistent with the presentinvention is illustrated in FIG. 20. FIG. 20 shows certain stepsassociated with a method of managing the “customers” of a treatmentsystem provider and the setup of the customer's system prior todelivery, recognizing that the customers of the system providers arephysicians, surgeons and other practitioners who provide therapeutictreatment. The method begins with a determination of the status of aselect practitioner as a new customer or a returning customer of thesystem provider (step 3000). If the practitioner is new, a new privateand public key pair is generated (step 3002) using any one of manywell-known public-key cryptosystems or similar technologies. Forexample, Lu, et al. U.S. Pat. No. 4,306,111 discloses a representativecryptosystem, which patent is incorporated herein by reference. Publicand private keys and other customer information such as identificationor billing information associated with the practitioner are stored to adatabase (step 3006). Prior to performing any system setup procedure, asetup operator must select the new or previously stored practitionerdata from the database (step 3008). The private key for the selectedpractitioner is read from the stored list (step 3010). Steps 3012, 3014and 3016 include reading a serial number or media access control address(MAC address) from the memory associated with an electrosurgical systemusing the MAC address or serial number as a seed for a hashing functionto encrypt a private key for storage in the system memory. As discussedabove in paragraphs 0194-0195, the system memory is in communicationwith the control for the system stimulation and ablation currentsources. Thus implementation of the steps illustrated on FIG. 20 assuresthat the system (when provided to a practitioner) may be used to deliveronly certain treatment protocols associated with the selectedpractitioner in accordance with the practitioner's established license,training and certification, as is described in greater detail below.

FIG. 21 includes a flow chart of the probe selection and orderingaspects of the system management method. As is described in detailherein, specific probes having specific physical parameters and energydelivery capacities may be prescribed or selected for the variousablation or nerve block procedures a practitioner may desire to perform.The following steps assure that the practitioner orders a correct probefrom a probe manufacturer or distribution center and that the correctprobes may be used only according to the intended treatment procedureand the practitioner's current license or certification. As describedbelow, additional steps also assure that the correct treatment protocolis delivered through the correct probe thereby enhancing patient safetyand treatment effectiveness.

The probe ordering process begins with order information provided by thesystem or the practitioner. Selection of the customer/practitioner (step3018) and retrieval of the practitioner's data (step 3020) from theencrypted customer database (step 3022) follows. Previously storedpractitioner data may be retrieved and if necessary decrypted (step3020, step 3022). Most importantly the prescribed probe protocolsassociated with the practitioner's system and certifications aredetermined (step 3024). At this point, the probe which is being orderedmust be matched with the protocols of intended use and thepractitioner's registered system, license and certification data. Thismatch could be accomplished manually; however, manual probe orderingintroduces the possibility of human error. Preferably, a sterilepackaged probe is interrogated via RF, optical or wired link forapproved treatment protocols. For example, the probe may be interrogatedfor approved protocols over a communications link (step 3026). This stepmay occur at the probe distribution location. In one embodiment thecommunications link is an RF link using ISO18000 part 3 protocoloperating at 13.56 Mhz. Other suitable wired or wireless communicationstrategies could be used as well. A determination must be made whetherthe probe matches the allowed treatment protocols associated with thepractitioner's system (step 3028). If no match occurs, an error messagewill be delivered in an automated implementation (step 3030 and step3032). If a match is registered, session keys for use by hashingfunctions will be generated (step 3034). The session keys and otherinformation are then written to memory associated with the selectedsterile probe (step 3036). In step 3038 the probe serial number isreturned to the system and a cyclic redundancy check (CRC) or other hashfunction is performed to verify both the correct serial number andproper information storage (step 3039). In a wireless implementation anincorrect CRC may result from communications failure. In this case, theprobe may be reoriented for a better signal (step 3040). Upon thecompletion of probe ordering, a probe self test will typically becompleted, before the probe is sent to a customer/practitioner.

FIG. 22 illustrates in flow chart form a wireless communication probeself-test. Accuracy and patient safety may be enhanced if the probeself-test occurs while the probe is still in a sterile container.Self-test is preferably accomplished prior to the delivery of a probe toa practitioner. After the correct probe is ordered as described above, acommand to a start self-test is issued in step 3041. A rectified RFfield can be used to power a processor and/or memory 331 associated witha preferred “smart” probe (See FIG. 1). One embodiment of the probeuses, for example, an Atmel AT90SC6408RFT power processor. Thisprocessor is particularly suitable for a smart probe since it includessecurity features such as: OTP (One Time Programmable) EEPROM area, RNG(Random Number Generator), side channel attack countermeasures, hardwareDES/TDES, CRC, ISO 14443 Type A & B contactless and serial interfaces. Asmart probe could also be implemented with other processors. Analternative embodiment of the probe, requiring identification only withless security functionality may be implemented with, for example anAtmel AT88SC0204CRF 2-Kbit user memory with authentication andencryption, an ISO/IEC 14443 Type B chip or other less full featuredprocessor.

In step 3041 the processor tests internal memory, the proper operationof the temperature sensor 311 and possibly other matters. A defectiveprobe will generate an error message (step 3042 and step 3044). In suchcase the defective probe serial number will be written to local storagebefore the probe is sent for repair (step 3046 and step 3048). A probepassing self-test operation 3041 will be subject to a write clear of theused probe flag as discussed in more detail below (step 3050).Verification of the write clear of the used probe flag is performed(step 3052), with a failed verification resulting in the errornotification and repair steps 3044-3048. If the write clear of the usedprobe flag is verified, the serial number of the probe is written to arecord for inventory control (step 3054). This method permits the selectprobe to be tracked to a specific end user. The public key systemdetailed above keeps any given probe from accidentally or intentionallybeing used in non-certified equipment. Once the probe is self-tested itmay be shipped to the practitioner (step 3056).

The methods detailed above and illustrated on FIGS. 20-22 include stepswhich will enhance patient safety and ultimate procedure effectivenessprior to the time a probe or system is delivered to a practitioner forthe performance of an ablation, nerve block or other electrosurgicalprocedure. Additional steps may be included in the system managementmethod which provides protection immediately prior to or during aprocedure. The FIG. 23 flowcharts illustrate certain probe usage andsafety features which may be implemented immediately prior to or duringa therapeutic procedure. In step 3060 of FIG. 23A a probe is removedfrom sterile packaging and connected to an ablation or stimulationcurrent source control system such as the generator 400 of FIG. 1. Theprocessor associated with the control console establishes communicationwith the probe over a serial bus 403, an RF Link, or through anothercommunication pathway (step 3062). A failure of the communication linkwill result in a prompt to reconnect the probe (step 3064 and step3066). Successful establishment of communication causes a date and timeto be read for the generation of session codes for hashing functions(step 3067 and step 3068). In step 3070 the system reads the probeserial number, public key(s) and certified protocols generated andstored as described above. The system may then verify that the privatekey associated with the generator and the public key match (step 3072).This step assures that a properly ordered probe can only be used in anauthorized system. If no match is observed, an error massage isdisplayed (step 3074).

Assuming that the probe and control system or generator keys match, thesystem performs a pre-use probe self-test and calibration (step 3076).At this point in the process, the probe might be identified asdefective, out of calibration or the prior use flag associated with theprobe might be active, indicating a non-sterile probe which will resultin an appropriate error message (step 3078 to step 3084). When a probepasses self-calibration, the serial number is read and the selectedtreatment protocol or selected energy bolus is matched with theauthorized protocols for the probe (steps 3086 and 3088). In the eventof a mismatch, an error message may be generated (step 3090). If asuccessful match is found the practitioner may insert the probe toperform a therapeutic protocol (step 3094). Representative therapeuticprotocols are described above in Paragraphs 0163-0170 and illustrated inFIGS. 5A-5B.

As shown on FIG. 23B, with the probe in position, a treatment protocol,alternatively known as an energy bolus may be loaded into the generatorsystem (step 3096). The total energy required by the selected bolus iscalculated (step 3098) and an estimated temperature profile iscalculated (step 3100) from a known energy delivery profile. Theoperator may press a front panel arm switch or otherwise arm the systemonce the practitioner has received consent of the patient to proceed.The system reads the arm switch (step 3102) and verifies the system tobe armed (step 3104). A supplemental practitioner arming step, forexample, a foot switch, further assures patient safety. Thus, thepractitioner may press a foot switch to enable the delivery of RF energywhen ready. The system reads the activation of the foot switch (step3106) and waits until the practitioner requests energy delivery (step3108) at which point the amplifier is turned on (step 3110).

Real power is then measured (step 3112) as energy is delivered withpower being integrated (step 3114) for total energy delivered. Theoptional probe temperature sensor is read and or a temperature profileis calculated (step 3116). For example, a 2D thermal model may be solvedfor real time temperature estimates assuming circular ablation lesionsymmetry (step 3119). If the temperature is determined to be greaterthan desired as in step 3118, power is reduced (step 3120). If thetemperature is less than desired, power is increased (step 3122). Thewatchdog timer is read at each step (step 3124). If the watchdog timeris timed out, there has possibly been a software or hardware failure andthe RF amplifier is turned off (steps 3126, 3128). If the watchdog timeris not timed out the step timer is incremented (step 3130). If thecurrently selected protocol or energy bolus step timer has elapsed (step3132) a step counter is incremented, the timer is reset (step 3134) andthe next step (3136) is loaded for execution. If the last stepassociated with a select bolus is finished (step 3138), the energydelivery is terminated (step 3128). The foregoing steps assure that anintegrated system as described herein will only deliver a prescribedtherapeutic dosage, also known as an energy bolus. Thus over-treatmentor burns may be avoided, enhancing patient safety.

As illustrated in FIG. 23C, upon completion of a procedure, the probetemperature and impedance is read (step 3140). High impedance and atemperature below body temperature (step 3142) indicate that the probeis removed from body and the operator is prompted by the system if done(step 3144). If no reply is received from the operator (step 3146), thetimer is incremented (step 3148). If the timer has timed out (step 3150)or if an affirmative reply is received (step 3146), the probe used flagis set (step 3152) in probe memory 331 and the controller 400 serialnumber and date are written to probe memory (step 3154). Also the probeserial number, date, time, and any sampled treatment data are written tosystem memory (step 3156).

In summary, the steps illustrated on FIGS. 23A-C serve to verify thatthe probe is sterile (not used), properly calibrated and not defective.These steps also assure that the probe matches the current source orgenerator console, that the probe matches the certified treatmentprotocols for the practitioner and that the maximum treatment timedosage for a given treatment protocol is not exceeded. Thus the abovesteps assure that the probe and system are properly used to supply theselected treatment protocol, enhancing patient safety and treatmenteffectiveness.

FIG. 24 is a flowchart illustrating a data writing procedure suitablefor documenting information at the conclusion of the treatmentprocedure. If the selected probe has timed out during the procedure, anerror message is generated (step 3200, step 3202). Otherwise, proceduredata is retrieved from the system and a report is generated (step 3204,step 3206) the report may be saved, or displayed on the user display 450(See FIG. 1). The report may be encrypted (step 3210) and include, butnot be limited to, the probe serial number, the procedure time/date, thetherapeutic protocol(s) used, current source current and runtime data,temperatures, impedances and error messages. Similarly encrypted datamay be written to the probe memory 331 (see FIG. 4), including but notlimited to the system generator serial number, protocol, and date (step3210). In addition, the probe-used flag must be set to a used status inthe probe flash memory 331 (step 3212).

The system of the present invention is preferably implemented with anintegrated and attractively packaged control console which includeswithin one or related multiple housings a stimulation current source, anablation energy source, and a practitioner interface unit. See FIG. 1for example. The practitioner interface, particularly if implemented asa computer style monitor, with or without touch screen capacity alsoprovides for novel training and system use control methods. For example,the system may be used to store and display practitioner training,promotional and client multimedia files for each procedure/protocol.Interactive multimedia files may be included to instruct a practitionerin the numerous safety features, therapeutic protocol or energy bolusprescriptions and nerve location methods taught herein. Similarmultimedia files may be used to teach the protocol system settings andlocation of anatomical landmarks. The training and other multimediamaterials may be customized for each practitioner. Thus the fullyintegrated system described herein may be used to provide ongoingpractitioner training thereby assuring patient safety and procedureeffectiveness.

Therapeutic Treatment Protocols

As disclosed herein tissue ablation or a nerve block or other minimallyinvasive electrosurgical procedure may be performed with preciselyapplied RF energy. A fundamental requirement of the therapeutic RFwaveform is to heat and denature human tissue in a small area over aselected time frame, for example, less than 25 seconds. Laboratoryexperiments indicate this to be a suitable time required to adequatelyablate a small motor nerve. Longer or shorter treatment times may berequired for other applications. The temperature required to denaturethe fine structure of the selected tissue, primarily proteins and lipidsis approximately 65° C. and above.

To safely achieve appropriate ablation, nerve block or other treatmentgoals, the RF waveform may be generated and applied to meet thefollowing criteria:

-   -   1. The probe temperature will be limited to less than 160° C. in        order to prevent excess damage to collateral tissue areas.    -   2. The probe temperatures will preferably be held to between 90°        and 105° C. This range will prevent excessive tissue sticking as        well as aid in the growth of an appropriate ablation lesion.

Initial RF power application should bring the temperature of the probetip to a working therapeutic temperature in controlled manner, causingminimal overshoot. The time frame for the initial warming phase may bebetween 0.2 to 2.5 seconds.

To achieve the foregoing generalized goals, specific treatment protocolsmay be developed. In one embodiment of the present invention, thedelivery of a specific therapeutic protocol (also described as an“energy bolus”) herein is automated. Automation can increase safety andtreatment effectiveness since the practitioner may concentrate on probeplacement while the system assures the delivery of the selected energybolus. For example, the system controller 401 may be configured tocontrol the waveform of energy supplied to an electrosurgical probeconnected to the system. In particular, the wave shape, waveformmodulation or pulse time may be controlled. Also, the total time duringwhich power may be applied and maximum power or voltage limits may beset. In addition, a specific treatment protocol may be activelycontrolled according to feedback such as the probe temperature, adjacenttissue temperature, tissue impedance or other physical parameters whichmay be measured during the delivery of treatment energy. Specific energydelivery prescriptions or energy boluses may be developed for specifictreatment goals. These energy prescriptions may be stored in memoryassociated with the controller as a permitted therapeutic protocol. Arepresentative therapeutic energy protocol 3250 is shown in tabular formon FIG. 25.

The therapeutic protocol 3250 of FIG. 25 is optimized for thetherapeutic ablation of a human nerve having a diameter of approximately1 millimeter. As shown on FIG. 26, the treatment protocol 3250 isgenerally designed to rapidly heat tissue during an initial phase 3252.Rapid heating during the initial phase has been shown to minimizeperceived pain and reduce muscle stimulation from the subsequentapplication of pulsed RF energy. A second phase 3254 includes constantpower application resulting in a slower ramp to a desired therapeutictissue/probe temperature. As also shown on FIG. 26, a third phase 3256includes the maintenance of a constant temperature at reduced power togrow the ablation lesion to a desired size.

The therapeutic treatment protocol 3250 illustrated on FIGS. 25 and 26is only one treatment protocol which has been found suitable for theablation of a small motor nerve. Other treatment protocols may bedeveloped for other or the same therapeutic goals. In all cases, thelevel of tissue ablation is substantially exponentially related to theproduct of time and temperature above 40° C. as is well known in the artas the Arrhenius rate. Thermal heat transport through target tissue maybe calculated with a finite difference algorithm. Tissue properties maybe specified on a 2D mesh and such properties can be arbitrary functionsof space and time. Arrhenius rate equations may be solved for the extentof ablation caused by elevated temperatures. In addition, optical andelectrical properties which are characteristic of ablated tissue may bemeasured and determined through histological studies. Thus, varioustherapeutic protocols such as that illustrated in FIGS. 25 and 26 may bedeveloped and optimized for the controlled achievement of desiredtherapeutic results. Preferably the therapeutic protocols areautomatically delivered to assure that the selected energy bolus isprecisely delivered.

As described above, the system may be configured to deliver a prescribedenergy bolus automatically. Automated energy delivery can increasesafety and treatment effectiveness, since the practitioner is free toconcentrate on probe placement. The goals of enhanced patient safety andtreatment effectiveness can be further advanced by providing anergonomically appropriate probe with associated switches and controlfunctions providing the practitioner with a tool that allows him toeasily and safely initiate the automated delivery of an energy boluswhile concentrating on probe placement. For example, FIG. 27 is aperspective view of an electrosurgical probe 3260 consistent with thepresent invention held by practitioner's hand. The probe 3260 includesan ergonomic probe handle 3262 which is symmetrical allowing for left orright handed operation. A sealed rocker switch 3264 is located at theforward ⅓ of handle 3262 for operation with the practitioner's indexfinger or thumb. Although a rocker switch is shown in FIG. 27, othermulti-function switch styles are suitable for the implementation of thisaspect of the invention. A light indicator 3266 is installed on thehandle 3262 near the probe needle 3268 to signal the system generatorstatus. The needle has an exposed return electrode 3270, insulator 3272and blunt active electrode 3274. In use, the blunt active electrode 3274is inserted in proximity to a target nerve.

During the process of probe placement, the stimulation current level maybe increased or decreased as described herein by sequentially depressingone of the forward or rearward sides of the rocker switch (see arrows3276 and 3278) thus closing internal switches 314 and 315 respectively.A speaker associated with the system may emit a tone having a volume orfrequency or other sound attribute substantially proportional to theamplitude setting of the stimulation current with each switch closure.This feature permits the practitioner to adjust the stimulation levelwithout the necessity of adjusting any level dials or switchesassociated with the generator, allowing the practitioner to focus oncritical probe placement.

When the stimulation process is complete, and the probe is positionedfor treatment, the practitioner may depress switch 3264 at the center(see arrow 3280), thus closing both switches and commanding thegenerator to arm the ablation current source. It should be noted thatthe blunt tip embodiment permits iterative probe placement whileminimizing the risk of cutting arteries or other structures as with achisel or pointed tip. When the rocker switch is centrally depressed,the light 3266 may illuminate a select color, green for example,signaling to the practitioner that the system is ready to apply RFablation energy. Without moving the probe, a pre-selected RF energybolus may be delivered by closure of a foot switch (not shown). Lightsource 3266 may illuminate a different color, blue for example, duringthe application of RF ablation energy. In addition, the system generatormay be configured to emit a tone signaling energy delivery. Thus, thedisclosed probe and system may be used by a practitioner to skillfullyimplement one of the probe location and placement methods describedherein, followed by the initiation of the automatic delivery of aselected energy bolus.

While the invention has been particularly shown and described withreference to a number of embodiments, it would be understood by thoseskilled in the art that changes in the form and details may be made tothe various embodiments disclosed herein without departing from thespirit and scope of the invention and that the various embodimentsdisclosed herein are not intended to act as limitations on the scope ofthe claims.

What is claimed is:
 1. A method of treating a nerve comprising:inserting a single longitudinal probe through a single puncture site ina layer of skin; directing the probe tip towards the nerve; delivering astimulating current through an electrode on the probe, observing aresponse of a muscle associated with the nerve; and applying an ablationcurrent to ablate the nerve at a first location upon observing theresponse; moving the probe in a direction axially along the nervewithout removing the probe from the puncture site; applying additionalablation current to further ablate the nerve at a subsequent location tomore effectively terminate a signal conduction through the nerve.
 2. Themethod of claim 1, where moving the probe in the direction relative tothe nerve comprises moving the probe and repeating delivering of thestimulating current through the electrode on the probe and Observing aresponse of the muscle associated with the nerve to determine if adesired level of conduction is achieved for completion of the treatment.3. The method of claim 1, where moving the probe in the directionrelative to the nerve comprises moving the probe in a forward directiondistally to a first ablation area along the nerve.
 4. The method ofclaim 1, further comprising performing rotating motions with the probeto increase an area of ablation and permanence of the procedure.
 5. Themethod of claim 1, moving the probe in a direction relative to the nervewithout removing the probe from the puncture site.
 6. The method ofclaim 1, where delivering the stimulating current and observing, theresponse of the muscle associated with the nerve comprises relocatingthe probe closer to the nerve if the response is not observed andrepeating delivering of the stimulating current.
 7. The method of claim1, where moving the probe in the direction comprises moving the probeup, down, near, far, circular, or in a pattern.
 8. A method of locatingand treating a nerve comprising: inserting a single longitudinal probethrough a single puncture site in a layer of skin; positioning the probetip in close proximity to said nerve; delivering a stimulating currentthrough an electrode on the probe; not detecting a response of a muscleassociated with said nerve; readjusting the position of the probe tip;delivering a stimulating current through an electrode on the probe;observing a response of a muscle associated with said nerve andobserving a degree of the response; ablating the nerve at a firstlocation with the probe tip; and moving the probe in a direction axiallyalong the nerve without removing the probe tip from the puncture siteand ablating the nerve at a second location to more effectivelyterminate a signal conduction through the nerve.
 9. The method in claim8 wherein, said readjusting the probe tip position is performed througha single puncture site without withdrawing the probe out of the puncturesite.
 10. The method of claim 9, further comprising delivering ablationenergy to the nerve to terminate a signal conduction through the nerve;and advancing the probe in a distal direction along the nerve tostimulate and ablate a second area along the nerve.
 11. A method ofablating a nerve comprising: locating the nerve by inserting a singlelongitudinal probe through a single puncture site in a layer of skin;positioning the probe tip in close proximity to said nerve; delivering astimulating current through an electrode on the probe; observing aresponse of a muscle associated with said nerve and observing a degreeof the muscle response to determine a proximity of the electrode to thenerve; ablating the nerve by delivering energy through electrodes onsaid probe sufficient to ablate the nerve at a first location;confirming the ablation of the nerve by delivering a stimulating currentthrough an electrode on the probe to determine feedback as to a qualityof the ablation; and moving the probe tip axially along said nerve toablate to the nerve at a second location axially spaced from the firstlocation without removing the probe tip from the nerve.
 12. The methodin claim 11, wherein, said locating, ablating and confirming isperformed through a single puncture site without withdrawing the probeout of the tissue.
 13. The method of claim 11, wherein, the nerve isablated in multiple sites.
 14. The method of claim 13, wherein, thenerve ablation sites are sequential in the direction of insertion of theprobe.
 15. The method of claim 13, wherein, the nerve ablation sites aresequential in the direction of withdrawal of the probe.